drug_approval_id
string
docid
int64
appl_no
string
if_validation
int64
data_status
string
data_source
string
lang
string
created_ts
string
updated_ts
string
created_by
string
updated_by
string
first_approval_date
dict
drug_id
list
disease_id
list
org_master_entity_id
list
dev_status_org_master_entity_id
list
source_url
string
rn
int64
submission_classification
unknown
indication_milestone
list
dosage_form_and_route
list
regulation
list
approval_drug_id
list
if_generic
int64
if_biosimilar
int64
revision_number
string
if_patient_safety
int64
therapeutic_area_mesh
list
atc_code
list
contact_address
list
treatment_group
list
latest_approval_date
dict
trade_name
list
active_ingredient
list
common_name
list
applicant
list
market_status
list
basic_drug_id
list
manual_approval
int64
version
int64
appl_type
string
therapeutic_equivalent
list
history_appl_infos
list
bla_type
dict
0022928e485282a285ea3a95828a55d0
335,150
125589
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:07:23.000Z
2026-04-20T01:05:10.000Z
data@patsnap.com
data@patsnap.com
null
null
[ "050361ea4037457398810941c515b5c1" ]
[ "c2c493b2551a70489c935a0d146217a8" ]
[ "c2c493b2551a70489c935a0d146217a8" ]
null
1
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1521590400000 }, "approval_disease_id": "050361ea4037457398810941c515b5c1", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125589-20180321" } ]
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Babesia microti AFIA/Babesia microti AFIA for Blood Donor Screening\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Imugen Babesia microti Nucleic Acid Test (NAT)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Oxford Immunotec Ltd\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
025e22d55eed45055e9e8e95ed2e595e
333,916
103821
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:32:41.000Z
2026-04-20T01:05:01.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 910828800000 }
[ "0c2c6511b92644d39bcbe7431a3816b4" ]
[ "b197e8523bf6466da02a97c8fcf2568c" ]
[ "5f965544d69ba88c5f6828760466a5af" ]
[ "5f965544d69ba88c5f6828760466a5af" ]
null
2
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 910828800000 }, "approval_disease_id": "b197e8523bf6466da02a97c8fcf2568c", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103821-20180220" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }, { ...
null
[ "0c2c6511b92644d39bcbe7431a3816b4" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 910828800000 }
[ "{\"name\":\"Biothrax\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anthrax Vaccine Adsorbed\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Emergent BioDefense Operations Lansing, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Emergent BioDefense Operations Lansing LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
02ad352e3ea3eee82e8ae225884e928a
322,548
125681
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:43:20.000Z
2026-04-20T01:06:21.000Z
data@patsnap.com
shimeihua@patsnap.com
null
null
null
[ "39edd1bb13fc3baeb87b864b2ffced1e" ]
[ "39edd1bb13fc3baeb87b864b2ffced1e" ]
null
3
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Alinity s Anti-HBc\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis B Virus Core Antigen (E. coli, Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Abbott GmbH & Co. KG\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
02ad50ae5e92ae9382ea0e2d2290e5a2
600,068
125786
1
ACTIVE
FDA_CBER
EN
2024-04-28T01:56:09.000Z
2026-04-20T01:05:30.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 1714003200000 }
[ "78a8164a2a4a469689767b0350137ffb" ]
[ "e30a25b1033043c4adf00e944889533c" ]
[ "9597e75ba30c9958d4331f586407d7cf" ]
[ "9597e75ba30c9958d4331f586407d7cf" ]
null
4
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1714089600000 }, "approval_disease_id": "e30a25b1033043c4adf00e944889533c", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125786-20240426" }, { "approval_disease_id": "e30a25b1033043c4adf00e944889533c...
[ { "dosage_form": [ { "name": "Suspension", "normalized_id": "4d250073d7a54d71b5c3cbb005efc5a3" } ], "name": "Suspension; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "78a8164a2a4a469689767b0350137ffb" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1714003200000 }
[ "{\"name\":\"BEQVEZ\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"fidanacogene elaparvovec-dzkt\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Pfizer Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
1
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
033238889e5a8a822a855832a025ee04
322,451
101094
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:25.000Z
2026-04-20T01:06:12.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 248918400000 }
[ "95c9f8f70f3d4f6babd6aa38962ea7ba" ]
[ "862e74fcd5744d1a914d10fe1dd67b70" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
null
5
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 248918400000 }, "approval_disease_id": "862e74fcd5744d1a914d10fe1dd67b70", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA101094-20211028" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }, { ...
null
[ "95c9f8f70f3d4f6babd6aa38962ea7ba" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 248918400000 }
[ "{\"name\":\"Pneumovax 23\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Pneumococcal Vaccine, Polyvalent\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Merck &Co, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharp & Dohme LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
03545ae5285823a88522a822883a2022
333,874
103375
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:49.000Z
2026-04-20T01:04:41.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 723945600000 }
[ "01ce4075743a493baa6b35f3714e2155" ]
[ "07d4cf59dafc4a35840dbf53e136394a" ]
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
6
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 723945600000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103375-20180305" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "01ce4075743a493baa6b35f3714e2155" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1268179200000 }
[ "{\"name\":\"Bioclate (Armour), Recombinate\",\"lang\":\"EN\"}", "{\"name\":\"Recombinate\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic Factor (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Baxter Healthcare Corporation\",\"lang\":\"EN\"}", "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
044e52a58050a20559a82d4a02295dee
322,545
125688
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:39:47.000Z
2026-04-20T01:04:51.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "8cf454a3525011cae6164f45edb24ff8" ]
[ "8cf454a3525011cae6164f45edb24ff8" ]
null
7
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent, Anti-k (Monoclonal)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagent\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Immucor, Inc.\",\"lang\":\"EN\"}" ]
null
null
null
2
BLA
null
null
null
0522e85ae228805a24058202d8545e92
322,367
103871
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:23.000Z
2026-04-20T01:04:41.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": -1445472000000 }
[ "6b27f26776cc4e18b8c24703da557685" ]
[ "d87b828805344058888243d7dc618051", "8bd674d9906f4c858aad1fa6ac211280", "d514ca46147040b3b74bdb2977860449", "e437e1bf7a0d4b309027a6d4bfead264" ]
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
null
8
null
[ { "action_date": { "time_trust_code": 7, "time_ts": -1445472000000 }, "approval_disease_id": "e437e1bf7a0d4b309027a6d4bfead264", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103871-20240614" }, { "action_date": { "time_trust_code": 7, "tim...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "6b27f26776cc4e18b8c24703da557685" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1445472000000 }
[ "{\"name\":\"Standardized Mite Extract\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Dermatophagoides pteronyssinus\",\"lang\":\"EN\"}", "{\"name\":\"Insects (Whole Body), Mite Dermatophagoides pteronyssinus\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Jubilant HollisterStier LLC\",\"lang\":\"EN\"}", "{\"name\":\"Jubiliant HollisterStier LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0532a0485e3383eeaa85253922ae98a8
322,523
125317
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:39:49.000Z
2026-04-20T01:06:20.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1232064000000 }
[ "f68acb85bed640f789777e2ffd01c0f3" ]
[ "71d86eb1f39c4e509b8da8fe4343bdd3", "a878e836d10f4f3092ac081350b250c6" ]
[ "e6ced78f036e804a7102f46703025f04" ]
[ "e6ced78f036e804a7102f46703025f04" ]
null
9
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1232064000000 }, "approval_disease_id": "71d86eb1f39c4e509b8da8fe4343bdd3", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125317-20210629" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "f68acb85bed640f789777e2ffd01c0f3" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1232064000000 }
[ "{\"name\":\"Riastap\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Fibrinogen Concentrate (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring GmbH\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0545a84d92e85d882aa02e8e382e4482
322,351
103890
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:16.000Z
2026-04-18T01:05:02.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1445472000000 }
[ "060c84bd5efd477883c886ff520e2516" ]
null
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
null
10
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "060c84bd5efd477883c886ff520e2516" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1445472000000 }
null
[ "{\"name\":\"Animal Allergens, Standardized Cat Pelt\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Jubilant HollisterStier LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
055255e2e44a08a2d229959d8aea5220
334,423
125761
1
ACTIVE
FDA_CBER
EN
2023-07-22T01:28:31.000Z
2026-04-20T01:08:00.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1689811200000 }
[ "7f531b143ada4aa8ad7595acb4d6a9d3" ]
[ "b197e8523bf6466da02a97c8fcf2568c" ]
[ "528b227ae0ed19512378353bdb9d3ba7" ]
[ "528b227ae0ed19512378353bdb9d3ba7" ]
null
11
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1689811200000 }, "approval_disease_id": "b197e8523bf6466da02a97c8fcf2568c", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125761-20230721" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "7f531b143ada4aa8ad7595acb4d6a9d3" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1689811200000 }
[ "{\"name\":\"CYFENDUS\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anthrax Vaccine Adsorbed, Adjuvanted\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Emergent Product Development Gaitherburg, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Emergent Product Development Gaithersburg, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
05934e5a505a53e89e33a30525e855a2
322,509
125105
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:32:16.000Z
2026-04-20T01:09:20.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1114560000000 }
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
[ "03eb5d3e15c14dca9bf67d355a8d20be", "cb8ba1ca66824102b6cf2f34e39bdc3e", "8b0644971f31409283cac32a7d08fd52" ]
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
12
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1114560000000 }, "approval_disease_id": "03eb5d3e15c14dca9bf67d355a8d20be", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125105-20180226" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous, Subcutaneous", "route": [ { "name": "Subcutaneous", "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" }, ...
null
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1114560000000 }
[ "{\"name\":\"Gammagard Liquid\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Immune Globulin Infusion (Human)\",\"lang\":\"EN\"}", "{\"name\":\"Immune Globulin Intravenous (Human), 10% Solution\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Baxter Healthcare Corp\",\"lang\":\"EN\"}", "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
08e22022a385d8a52998d8e928ea23d4
322,504
103779
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:35:26.000Z
2026-04-20T01:04:31.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 993600000000 }
[ "dd3a9e545b0a48d09e2865951999c161" ]
[ "07d4cf59dafc4a35840dbf53e136394a" ]
[ "7bc63f6fd36e03dcca041bb8aa3c35d7", "f8f93aefb248d83b7d03ae5998b2c2c3" ]
[ "7bc63f6fd36e03dcca041bb8aa3c35d7", "f8f93aefb248d83b7d03ae5998b2c2c3" ]
null
13
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 993600000000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103779-20180223" }, { "action_date": { "time_trust_code": 7, "time_...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "dd3a9e545b0a48d09e2865951999c161" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 994377600000 }
[ "{\"name\":\"Refacto\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic Factor (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Genetics Institute, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Wyeth Pharmaceuticals LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0a24292d2222e2d39492998a94e548ae
322,407
102217
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:10.000Z
2026-04-18T01:04:41.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 132278400000 }
[ "538c532a2ab64e149acddd8493478028" ]
null
[ "120a7f68c33321cc79b6556a3842e1d9" ]
[ "120a7f68c33321cc79b6556a3842e1d9" ]
null
14
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "538c532a2ab64e149acddd8493478028" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 132278400000 }
null
[ "{\"name\":\"Pollens - Grasses, Orchard Grass Dactylis glomerata\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allermed Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0a289a2d849283a2e822a4532d955829
322,531
102692
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:36:39.000Z
2026-04-20T01:04:51.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "8cf454a3525011cae6164f45edb24ff8" ]
[ "8cf454a3525011cae6164f45edb24ff8" ]
null
15
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Anti-B (Murine Monoclonal)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anti-B (Murine Monoclonal)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Immucor, Inc\",\"lang\":\"EN\"}" ]
null
null
null
1
BLA
null
null
null
0aa822ea5e8259ea2e298eed2358ade5
334,223
103665
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:33.000Z
2026-04-20T01:06:12.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 922320000000 }
[ "4f12876533214e7aa2f8dc7b2346c345" ]
[ "18795373eb704b16936d51c793bbea01" ]
[ "663fbdfe9698d4aae0003f60ea4d98b4" ]
[ "663fbdfe9698d4aae0003f60ea4d98b4" ]
null
16
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 922320000000 }, "approval_disease_id": "18795373eb704b16936d51c793bbea01", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103665-20180223" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "4f12876533214e7aa2f8dc7b2346c345" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1281052800000 }
[ "{\"name\":\"NovoSeven\",\"lang\":\"EN\"}", "{\"name\":\"Novoseven, Novoseven Rt\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Coagulation Factor VIIa (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Novo Nordisk Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0aaa352a504985425d05e4e5d58a8ea8
335,074
125340
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:47:50.000Z
2026-04-20T01:04:51.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "9472fb2378c5276820bb3a479988861d" ]
[ "9472fb2378c5276820bb3a479988861d" ]
null
17
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Anti-K ALBAsera\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagents (ALBAsera)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Alba Bioscience Limited\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
0d822a04a8e4e8ae258a2485255a2a52
334,800
125445,125449, 125450, 125451, 125452, 125453, 125454, 125455, 125456, 125457
0
ACTIVE
FDA_CBER
EN
2022-03-12T08:03:32.000Z
2024-04-13T06:32:48.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "3cdd4425d164f395c0504ce8c7d1adfa" ]
[ "3cdd4425d164f395c0504ce8c7d1adfa" ]
null
18
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent, Anti-A (Murine Monoclonal)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagent Combination Kit\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Diagnostic Grifols, S. A.\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
0d8a880edd9ae33232042882e245aae8
334,627
125591
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:09:16.000Z
2026-04-20T01:06:21.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1464134400000 }
[ "a22f0837cb594581ac4bc59c14eb8493" ]
[ "07d4cf59dafc4a35840dbf53e136394a", "71d86eb1f39c4e509b8da8fe4343bdd3" ]
[ "2afd267a47d2c68ad059976b3932d1cb" ]
[ "2afd267a47d2c68ad059976b3932d1cb" ]
null
19
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1464134400000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125591-20200423" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "a22f0837cb594581ac4bc59c14eb8493" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1490918400000 }
[ "{\"name\":\"Afstyla\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic Factor (Recombinant), Single Chain\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring Lengnau AG\",\"lang\":\"EN\"}", "{\"name\":\"CSL Behring, LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0dd2e58825a35a9d5a5a8d4ee24250a2
334,029
125752
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:12:36.000Z
2026-04-20T01:06:32.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1643587200000 }
[ "1f1ffd7c81834108a897a8685a3feb52" ]
[ "717a9bf79e584830859595b8dbe9d433", "afd91398239d4ce484a65fb24e3eda53" ]
[ "74275107d346b274949eee8477168cac" ]
[ "74275107d346b274949eee8477168cac" ]
null
20
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1643587200000 }, "approval_disease_id": "717a9bf79e584830859595b8dbe9d433", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125752-20220218" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "1f1ffd7c81834108a897a8685a3feb52" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1752019200000 }
[ "{\"name\":\"Spikevax\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"COVID-19 Vaccine, mRNA\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ModernaTX, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0e0da5e98d03d02aae22de5884290205
322,541
125778
1
ACTIVE
FDA_CBER
EN
2023-07-08T01:33:27.000Z
2026-04-20T01:04:41.000Z
data@patsnap.com
shimeihua@patsnap.com
null
null
null
[ "1e9a34b6ee15d3652edb0b74c85f3816" ]
[ "1e9a34b6ee15d3652edb0b74c85f3816" ]
null
21
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Elecsys HIV Duo\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Elecsys HIV Duo\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Roche Diagnostics\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
0e228e52da90d33e20e28dee2a4558a8
322,521
103873
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:43.000Z
2026-04-18T01:05:03.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1445472000000 }
[ "f3fa6609684e4cb098b3d26ad2e52a08" ]
null
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
null
22
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "f3fa6609684e4cb098b3d26ad2e52a08" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1445472000000 }
null
[ "{\"name\":\"Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Jubilant HollisterStier LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0e3ea2d8ee920e95a59a5585a38440ae
322,567
125667
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:45:04.000Z
2026-04-20T01:05:30.000Z
data@patsnap.com
shimeihua@patsnap.com
null
null
null
[ "73c6ea22663f0739534fbf6cd2c618f6" ]
[ "73c6ea22663f0739534fbf6cd2c618f6" ]
null
23
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Procleix Zika Virus Assay\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Procleix Zika Virus Assay\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Grifols Diagnostic Solutions, Inc.\",\"lang\":\"EN\"}" ]
null
null
1
3
BLA
null
null
null
0e585aa2d8e3a323e350a99e082e2ee8
322,546
125098
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:40:09.000Z
2026-04-20T01:06:21.000Z
data@patsnap.com
data@patsnap.com
null
null
[ "fc5deabc9c1747e5bfc2ce1738e596ba" ]
[ "47d732945490e7eb4bd4dc914f75228d" ]
[ "47d732945490e7eb4bd4dc914f75228d" ]
null
24
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1517788800000 }, "approval_disease_id": "fc5deabc9c1747e5bfc2ce1738e596ba", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125098-20180205" } ]
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Anti-Human Globulin Anti-IgG IH-Card AHG Anti-IgG;Anti-Human Globulin Solidscreen II\",\"lang\":\"EN\"}", "{\"name\":\"Anti-Human Globulin Solidscreen II\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anti-Human Globulin\",\"lang\":\"EN\"}", "{\"name\":\"Anti-Human Globulin (Formulated for Automated Testing)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio-Rad Medical Diagnostics GmbH\",\"lang\":\"EN\"}", "{\"name\":\"Biotest AG\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
0e5922a240a255a34d5592e8350494a4
322,382
103171
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:56.000Z
2026-04-20T01:06:11.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1067817600000 }
[ "2dc24a47a14c4673b0208bb77164d93a" ]
[ "90a4f0aa8f4745188895e0cf401c3cac", "e255185bd59e4c2cbef67fd98444d16f" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
null
25
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1067817600000 }, "approval_disease_id": "90a4f0aa8f4745188895e0cf401c3cac", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103171-20191209" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "2dc24a47a14c4673b0208bb77164d93a" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1067817600000 }
[ "{\"name\":\"Tenivac\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Tetanus and Diphtheria Toxoids Adsorbed\",\"lang\":\"EN\"}", "{\"name\":\"Tetanus and Diphtheria Toxoids Adsorbed For Adult Use\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Sanofi Pasteur Limited\",\"lang\":\"EN\"}", "{\"name\":\"Sanofi Pasteur, Ltd\",\"lang\":\"EN\"}", "{\"name\":\"Sanofi Pasteur, Ltd, License #1726\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0ea04a5a5a429d5daae2ea044e22880e
334,427
125488
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:39:55.000Z
2026-04-20T01:05:11.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1430870400000 }
[ "80e341fdde524e49b9acfe68ac0d08b2" ]
[ "90234d23e7674dc1bb0c2169aa2049ba" ]
[ "832855b5a905d74ae5f51a5ca3ba5b74", "46854ca6357126e424b78b56858679ca" ]
[ "832855b5a905d74ae5f51a5ca3ba5b74", "46854ca6357126e424b78b56858679ca" ]
null
26
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1430870400000 }, "approval_disease_id": "90234d23e7674dc1bb0c2169aa2049ba", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125488-20210416" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "80e341fdde524e49b9acfe68ac0d08b2" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1430870400000 }
[ "{\"name\":\"Anavip\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Crotalidae Immune F(ab')2 (Equine)\",\"lang\":\"EN\"}", "{\"name\":\"Crotalidae Immune F(ab’)2 (Equine)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Instituto Bioclon, S.A. de C.V.\",\"lang\":\"EN\"}", "{\"name\":\"Rare Disease Therapeutics, Inc. (RDT)\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
0ea555eaaaa20e53e2038e5e3a045d2d
335,087
125792
1
ACTIVE
FDA_CBER
EN
2023-10-21T00:52:13.000Z
2026-04-20T01:04:41.000Z
data@patsnap.com
shimeihua@patsnap.com
null
null
[ "fc5deabc9c1747e5bfc2ce1738e596ba" ]
[ "1e9a34b6ee15d3652edb0b74c85f3816" ]
[ "1e9a34b6ee15d3652edb0b74c85f3816" ]
null
27
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1697500800000 }, "approval_disease_id": "fc5deabc9c1747e5bfc2ce1738e596ba", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125792-20231017" } ]
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Elecsys HTLV-I/II\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Elecsys HTLV-I/II\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Roche Diagnostics\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
0eda2a9a4523282e2253dd30ae3eeeaa
335,100
125686
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:39:04.000Z
2026-04-20T01:04:51.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "8cf454a3525011cae6164f45edb24ff8" ]
[ "8cf454a3525011cae6164f45edb24ff8" ]
null
28
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent, Anti-Fyb(Monoclonal)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagent\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Immucor, Inc.\",\"lang\":\"EN\"}" ]
null
null
null
2
BLA
null
null
null
0eea25229a55ee29aa5324253a25508e
333,992
125614
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:00:10.000Z
2026-04-20T01:09:41.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1508457600000 }
[ "1a35e4ea61a04f7b85f0d45521156705" ]
[ "d6d2753e6cbb4d7e8d5a68864c145fa4" ]
[ "3fae01860e648633ae0ebca1b62e7ba5" ]
[ "3fae01860e648633ae0ebca1b62e7ba5" ]
null
29
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1508486400000 }, "approval_disease_id": "d6d2753e6cbb4d7e8d5a68864c145fa4", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125614-20210802" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }...
null
[ "1a35e4ea61a04f7b85f0d45521156705" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1752624000000 }
[ "{\"name\":\"Shingrix\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Zoster Vaccine Recombinant, Adjuvanted\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"GlaxoSmithKline Biologicals\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2055858402285ed85d892e52ede40588
334,470
125384
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:36:21.000Z
2026-04-20T01:05:22.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1307059200000 }
[ "89824e4e9a5f4b8692b53dfd98007a54" ]
[ "b23f81936ad840f782543598080fccc8", "0c167d450cb14df0b7da57263b05f562", "7c2cb493c9d04ea28ef02c8e8ff476f8", "c9f585d1ec3e46b89bb7599c77c8a391", "7925449988aa4724bf9f75280531860f", "a7d76312a78349fe9c860a45ead4d9ab" ]
[ "fb3e2f7f9b0a4a9d1edc971dbb4940a2", "38bd1f8ca6cfd8bbdb677fbc84f61a09" ]
[ "fb3e2f7f9b0a4a9d1edc971dbb4940a2", "38bd1f8ca6cfd8bbdb677fbc84f61a09" ]
null
30
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1307059200000 }, "approval_disease_id": "7925449988aa4724bf9f75280531860f", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125384-20200911" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "89824e4e9a5f4b8692b53dfd98007a54" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1378339200000 }
[ "{\"name\":\"Kedbumin\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Albumin\",\"lang\":\"EN\"}", "{\"name\":\"Albumin (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Kedrion Biopharmaceuticals, SpA\",\"lang\":\"EN\"}", "{\"name\":\"Kedrion Biopharma Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
20d250085e9342ae02ae4032ae04a25a
334,387
103174
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:02.000Z
2026-04-20T01:04:31.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 565401600000 }
[ "746c2d45d7f04521b170104f37d46293" ]
[ "3f72c66155dd4bc6bb183f7147e9a04f" ]
[ "ba285f52362d5707e4cbab569e6cde8c" ]
[ "ba285f52362d5707e4cbab569e6cde8c" ]
null
31
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 565401600000 }, "approval_disease_id": "3f72c66155dd4bc6bb183f7147e9a04f", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103174-20180305" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] }, ...
null
[ "746c2d45d7f04521b170104f37d46293" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1583366400000 }
[ "{\"name\":\"Prolastin\",\"lang\":\"EN\"}", "{\"name\":\"Prolastin;Prolastin-C\",\"lang\":\"EN\"}", "{\"name\":\"prolastin,prolastin-c,prolastin-c liquid\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Alpha-1-Proteinase Inhibitor (Human)\",\"lang\":\"EN\"}", "{\"name\":\"Alpha1-Proteinase Inhibitor (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Grifols Therapeutics LLC\",\"lang\":\"EN\"}", "{\"name\":\"Talecris Biotherapeutics, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Talecris Biotherapeutics, Inc. License #1716\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
20d9252ea2e52ded55e2a5a59843a255
322,510
125596
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:04:56.000Z
2026-04-20T01:08:20.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1473724800000 }
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
[ "03eb5d3e15c14dca9bf67d355a8d20be" ]
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
32
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1473724800000 }, "approval_disease_id": "03eb5d3e15c14dca9bf67d355a8d20be", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125596-20210924" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Subcutaneous", "route": [ { "name": "Subcutaneous", "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" } ] } ]
null
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1549497600000 }
[ "{\"name\":\"Cuvitru\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Immune Globulin Subcutaneous (Human), 20% Solution\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Baxalta US, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
20de2308520823009a55a90490d80259
322,463
103972
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:34.000Z
2026-04-18T01:05:14.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 686880000000 }
[ "a0af922466f444c8a41cf097c28fde1e" ]
null
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
null
33
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, ...
null
[ "a0af922466f444c8a41cf097c28fde1e" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 686880000000 }
[ "{\"name\":\"Pharmalgen\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Venoms, White Faced Hornet Venom Protein\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK - Abello A/S\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22080355da5295a8aa8e45aeeae29a98
322,492
125284
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:32:20.000Z
2026-04-20T01:05:01.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1233878400000 }
[ "beecb3b63a35401aa1d773c166c3ce84" ]
[ "498fb53732ef45a7b40bba0bc402089f" ]
[ "16425215ed3885b2ef4d0817db0a3521" ]
[ "16425215ed3885b2ef4d0817db0a3521" ]
null
34
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1233878400000 }, "approval_disease_id": "498fb53732ef45a7b40bba0bc402089f", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125284-20180305" }, { "approval_disease_id": "498fb53732ef45a7b40bba0bc402089f...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "beecb3b63a35401aa1d773c166c3ce84" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1397174400000 }
[ "{\"name\":\"Atryn\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antithrombin (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"GTC Biotherapeutics, Inc\",\"lang\":\"EN\"}", "{\"name\":\"rEVO Biologics, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22205242258d598898d882ae58e58985
322,413
125201
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:32:51.000Z
2026-04-20T01:06:12.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1185408000000 }
[ "5b0b0cf69bd24f79a88b2725ec302189" ]
[ "03eb5d3e15c14dca9bf67d355a8d20be", "b9790aa2ed5c48eda26f2224870a8e52", "8b0644971f31409283cac32a7d08fd52" ]
[ "fb0c93f2602d78e54f5cb1533d67c850" ]
[ "fb0c93f2602d78e54f5cb1533d67c850" ]
null
35
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1185408000000 }, "approval_disease_id": "8b0644971f31409283cac32a7d08fd52", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125201-20180226" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "5b0b0cf69bd24f79a88b2725ec302189" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1360195200000 }
[ "{\"name\":\"Privigen\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Immune Globulin Intravenous (Human), 10% Liquid\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring AG\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
222a5238a488502958a48a8303580e5d
322,572
125670
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:06:10.000Z
2026-04-20T01:05:10.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "4d5a557c66947e16cf718f036e24def7" ]
[ "4d5a557c66947e16cf718f036e24def7" ]
null
36
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Geenius HIV 1/2 Supplemental Assay\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio-Rad Laboratories, Inc.\",\"lang\":\"EN\"}" ]
null
null
1
3
BLA
null
null
null
222ad8e0229a892225e52aaa095928aa
334,393
103882
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:24.000Z
2026-04-18T01:05:20.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1445472000000 }
[ "75b830ea6c0f423ab4c3fded9c107018" ]
null
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
[ "adef70c5aa13980072f0d5e6fa2b2616" ]
null
37
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, ...
null
[ "75b830ea6c0f423ab4c3fded9c107018" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1445472000000 }
null
[ "{\"name\":\"Venoms, Honey Bee Venom\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Jubilant HollisterStier LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2232e8da8e2e40a5a3ea00dde8305292
322,562
125216
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:55:30.000Z
2026-04-20T01:04:50.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "882244ad90818d645322c1828a22d976" ]
[ "882244ad90818d645322c1828a22d976" ]
null
38
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Seraclone\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagent Anti-S (Monoclonal)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Biotest Medical Diagnostics GmbH\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
2233052edd440a22258a3a8ee5a48ea3
334,369
125740
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:11:19.000Z
2026-04-20T01:05:10.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1628812800000 }
[ "6cc8522757714b439959196176ba8176" ]
[ "c7ebf4dbdeb0482abc5a9aa11742885b" ]
[ "3e5a778e673f3bd4d0f037b933e01302", "f5436398dd3fcd472a7371675cef4c9f" ]
[ "3e5a778e673f3bd4d0f037b933e01302", "f5436398dd3fcd472a7371675cef4c9f" ]
null
39
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1628812800000 }, "approval_disease_id": "c7ebf4dbdeb0482abc5a9aa11742885b", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125740-20210907" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "6cc8522757714b439959196176ba8176" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1628812800000 }
[ "{\"name\":\"Ticovac\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Tick-Borne Encephalitis Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Pfizer Ireland Pharmaceuticals\",\"lang\":\"EN\"}", "{\"name\":\"Pfizer Ireland Pharmaceuticals Unlimited Company\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2238d5925a54d2a825a8484a52e88d02
334,441
101075
1
ACTIVE
FDA_CBER
EN
2022-09-14T09:18:56.000Z
2026-04-18T01:04:33.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -17798400000 }
[ "82911e9b83964e8f9f890fc174a5b7c5" ]
null
[ "462096edf3de7b2de5a70c8fa9b70fa3" ]
[ "462096edf3de7b2de5a70c8fa9b70fa3" ]
null
40
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Subcutaneous", "route": [ { "name": "Subcutaneous", "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" } ] } ]
null
[ "82911e9b83964e8f9f890fc174a5b7c5" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -17798400000 }
[ "{\"name\":\"MERUVAX II\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Rubella Virus Vaccine Live\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Merck Sharp & Dohme LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2254508300a5e202209e5eaaea3528ed
322,511
103133
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:00.000Z
2026-04-18T01:04:41.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 509068800000 }
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
null
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
41
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "e3f5a214cdb64f0aa286f7b4b04160ac" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 964656000000 }
[ "{\"name\":\"Gammagard, Gammagard S/D, Iveegam\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Immune Globulin Intravenous (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
225838d228a3da382e20483a209a29d0
322,486
101379
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:25:33.000Z
2026-04-18T01:04:52.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1248134400000 }
[ "b88c27a4b6724ccf8904d73b47f87c3b" ]
null
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
null
42
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, { ...
null
[ "b88c27a4b6724ccf8904d73b47f87c3b" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1248134400000 }
null
[ "{\"name\":\"Pollens - Grasses, Bermuda Grass Cynodon dactylon\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allergy Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2258a8e800329e2dd854222e2eaa5e35
322,516
125577
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:40:32.000Z
2026-04-20T01:08:41.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1449532800000 }
[ "ee1104b59e6643118179130a32df100c" ]
[ "caa3ab7eaee24b2e847a80b722489355", "71d86eb1f39c4e509b8da8fe4343bdd3", "7ed28f2c0ea54b21860f336ace4c2994" ]
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
43
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1449532800000 }, "approval_disease_id": "caa3ab7eaee24b2e847a80b722489355", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125577-20220131" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "ee1104b59e6643118179130a32df100c" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1449532800000 }
[ "{\"name\":\"Vonvendi\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"von Willebrand factor (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2258ea205232a90892aeed595e4ddd22
334,165
125478
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:38:13.000Z
2026-04-20T01:06:31.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1397692800000 }
[ "3d4509aba3b94bf392fcea9b6bfd3686" ]
[ "00894c5beba2467fa4489e0fa39ddffa", "d87b828805344058888243d7dc618051" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde", "6632a5800bfb389a90c6b15df46d2020" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde", "6632a5800bfb389a90c6b15df46d2020" ]
null
44
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1397692800000 }, "approval_disease_id": "00894c5beba2467fa4489e0fa39ddffa", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125478-20210422" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Tablet", "normalized_id": "4148c1befb484d839ffe43ee3ed5b0dd" } ], "name": "Tablet; Sublingual", "route": [ { "name": "Sublingual", "normalized_id": "df42928ad27247499cb3c3fd66fa15c9" } ] } ]
null
[ "3d4509aba3b94bf392fcea9b6bfd3686" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1397692800000 }
[ "{\"name\":\"Ragwitek\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Allergen Extract Sublingual Tablets\",\"lang\":\"EN\"}", "{\"name\":\"Short Ragweed Pollen Allergen Extract\",\"lang\":\"EN\"}", "{\"name\":\"Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK - Abello A/S\",\"lang\":\"EN\"}", "{\"name\":\"ALK-Abello A/S, Horshlom Denmark\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharp & Dohme Corp\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
225ee24d25aaae00455032848a24ea28
334,894
101840
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:26:34.000Z
2026-04-18T01:04:30.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1248134400000 }
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
[ "0eadbae419b39df038ede0ce7d6bd7af" ]
[ "0eadbae419b39df038ede0ce7d6bd7af" ]
null
45
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1248134400000 }
null
[ "{\"name\":\"Pollens - Grasses, Redtop Agrostis alba\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Greer Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2288058ea2e59a458e5de0820d222230
334,159
125574
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:38:55.000Z
2026-04-20T01:07:01.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1458086400000 }
[ "3c6910f13384490baf1975b30dcefbb4" ]
[ "07d4cf59dafc4a35840dbf53e136394a" ]
[ "325e2f65e69a5b82d95b8c8faff3ed1c" ]
[ "325e2f65e69a5b82d95b8c8faff3ed1c" ]
null
46
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1458086400000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125574-20211102" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "3c6910f13384490baf1975b30dcefbb4" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1458086400000 }
[ "{\"name\":\"Kovaltry\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic Factor (Recombinant)\",\"lang\":\"EN\"}", "{\"name\":\"Antihemophilic Factor (Recombinant), Full Length\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bayer HealthCare LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22884352899e088a2a292e4a00e3d52e
322,380
103944
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:32:33.000Z
2026-04-18T01:05:40.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 951350400000 }
[ "2dc24a47a14c4673b0208bb77164d93a" ]
[ "e255185bd59e4c2cbef67fd98444d16f", "90a4f0aa8f4745188895e0cf401c3cac" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
null
47
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 951350400000 }, "approval_disease_id": "90a4f0aa8f4745188895e0cf401c3cac", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103944-20180221" }, { "action_date": { "time_trust_code": 7, "time_...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "2dc24a47a14c4673b0208bb77164d93a" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 951350400000 }
[ "{\"name\":\"Diphtheria and Tetanus Toxoids Adsorbed\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Diphtheria & Tetanus Toxoids Adsorbed\",\"lang\":\"EN\"}", "{\"name\":\"Diphtheria and Tetanus Toxoids Adsorbed, STN 103944\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Sanofi Pasteur, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Sanofi Pasteur Limited\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22a8329de29ea002252082420a80d52e
335,007
125737
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:21:44.000Z
2026-04-20T01:05:21.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 1638230400000 }
[ "fa8182015d9c4a9fa2fc23bed2b018d3" ]
[ "8b107203951e4ae9bfe9667fccbe8df9", "9a802adb6e94433f8f4eb9be678991b8" ]
[ "f2bfa2c871c59b1698390b7c4235659e" ]
[ "f2bfa2c871c59b1698390b7c4235659e" ]
null
48
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1638230400000 }, "approval_disease_id": "8b107203951e4ae9bfe9667fccbe8df9", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125737-20211213" }, { "approval_disease_id": "8b107203951e4ae9bfe9667fccbe8df9...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }...
null
[ "fa8182015d9c4a9fa2fc23bed2b018d3" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1638230400000 }
[ "{\"name\":\"Prehevbrio\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis B Vaccine (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"VBI Vaccines (Delaware), Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22aa5da8e95aa5a4502ea33aa8525a55
334,090
103059
1
ACTIVE
FDA_CBER
EN
2023-08-28T05:39:03.000Z
2026-04-18T01:04:55.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -607737600000 }
[ "2a331a812ec74771b98f584742db93ba" ]
null
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
null
49
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, { ...
null
[ "2a331a812ec74771b98f584742db93ba" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -607737600000 }
null
[ "{\"name\":\"Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK-Abello, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22aa8e08084288e9ed58a2a824e595d8
335,118
103762
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:45:42.000Z
2026-04-20T01:06:22.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "73cf2b8f828a3201a51e8a789e03d869" ]
[ "73cf2b8f828a3201a51e8a789e03d869" ]
null
50
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"ABBOTT PRISM HCV\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Abbott Laboratories\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
22d28d285daa55ed555825d2a932e23e
322,508
125562
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:34:46.000Z
2026-04-20T01:11:20.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1427155200000 }
[ "df484b002c4941598655a6b6dbe88414" ]
[ "d6989b71c5914849a7580823bd3c1e77" ]
[ "278f22669a4efe54c15eeddeb79edf3a", "9c58a700f57923220e84515d26fc0168" ]
[ "278f22669a4efe54c15eeddeb79edf3a", "9c58a700f57923220e84515d26fc0168" ]
null
51
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1427155200000 }, "approval_disease_id": "d6989b71c5914849a7580823bd3c1e77", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125562-20180308" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "df484b002c4941598655a6b6dbe88414" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1427155200000 }
[ "{\"name\":\"Anthrasil\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anthrax Immune globulin Intravenous\",\"lang\":\"EN\"}", "{\"name\":\"Anthrax Immune Globulin Intravenous (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Cangene Corporation\",\"lang\":\"EN\"}", "{\"name\":\"Emergent BioSolutions Canada Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22dd2ee2ee8ed559a8ad805aaee5a89e
334,902
102218
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:21.000Z
2026-04-18T01:04:44.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 132278400000 }
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
[ "120a7f68c33321cc79b6556a3842e1d9" ]
[ "120a7f68c33321cc79b6556a3842e1d9" ]
null
52
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 132278400000 }
null
[ "{\"name\":\"Pollens - Grasses, Redtop Agrostis alba\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allermed Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
22e23a8e5ea482ad5dd3a025495228d0
322,539
125759
1
ACTIVE
FDA_CBER
EN
2022-09-17T00:10:41.000Z
2026-04-20T01:06:20.000Z
data@patsnap.com
data@patsnap.com
null
null
[ "9a802adb6e94433f8f4eb9be678991b8", "5f0765227409473d803995e585313374" ]
[ "39edd1bb13fc3baeb87b864b2ffced1e" ]
[ "39edd1bb13fc3baeb87b864b2ffced1e" ]
null
53
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1658966400000 }, "approval_disease_id": "5f0765227409473d803995e585313374", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125759-20220728" } ]
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Alinity s Anti-HCV II assay\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Abbott GmbH\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
22e85ee85d52daae25430aa2e999a954
322,497
125168 - 125177, 125187
0
ACTIVE
FDA_CBER
EN
2024-03-02T07:45:37.000Z
2024-04-13T06:27:33.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "e23121ed295477dc56f0d5814a8fa246" ]
[ "e23121ed295477dc56f0d5814a8fa246" ]
null
54
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Reagent Red Blood Cells A1 Cells / B Cells\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"OLYMPUS PK Systems Blood Grouping and Phenotyping Reagents\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"DIAGAST\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
2354234a58d84285de2a9e4a40a20044
334,877
125768
1
ACTIVE
FDA_CBER
EN
2024-03-02T07:43:21.000Z
2024-06-12T05:51:47.000Z
data@patsnap.com
data@patsnap.com
null
[ "d7806e9c1c1f42b38fba4f754abe14ed" ]
[ "21596fe3eb8541c8b661ee50ba37ec61" ]
[ "9597e75ba30c9958d4331f586407d7cf" ]
[ "9597e75ba30c9958d4331f586407d7cf" ]
null
55
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1694649600000 }, "approval_disease_id": "21596fe3eb8541c8b661ee50ba37ec61", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125768-20230914" } ]
null
null
[ "d7806e9c1c1f42b38fba4f754abe14ed" ]
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"ABRYSVO\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Respiratory Syncytial Virus Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Pfizer Inc.\",\"lang\":\"EN\"}" ]
null
null
null
1
BLA
null
null
null
2388e5a2285eee522e88d52858458aaa
334,674
125094- 097; 125202 -  206
0
ACTIVE
FDA_CBER
EN
2022-03-12T08:07:30.000Z
2024-04-13T06:26:37.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "47d732945490e7eb4bd4dc914f75228d" ]
[ "47d732945490e7eb4bd4dc914f75228d" ]
null
56
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent IH-Card ABO/D(DVI-)+Rev A1,B\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"IH-Card\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio-Rad Medical Diagnostics GmbH\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
238aee0429a502e23ae3e84284a8a852
334,525
101099
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:01.000Z
2026-04-18T01:04:32.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -74044800000 }
[ "93b18b27982945519fa3d5b9f00525d3" ]
null
[ "7bc63f6fd36e03dcca041bb8aa3c35d7" ]
[ "7bc63f6fd36e03dcca041bb8aa3c35d7" ]
null
57
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "93b18b27982945519fa3d5b9f00525d3" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -74044800000 }
[ "{\"name\":\"Micrurus Fulvius\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antivenin (Micrurus fulvius)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Wyeth Pharmaceuticals LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
23a4e8288a2243220822902242e0054a
322,405
125446
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:38:31.000Z
2026-04-20T01:05:40.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1372204800000 }
[ "4ceb0eaafaa9457baa2ec09076cfd008" ]
[ "c430a48a9cc04b12afd9da415bd5cc56" ]
[ "4099573c333dcbc48d8f398aee392060" ]
[ "4099573c333dcbc48d8f398aee392060" ]
null
58
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1372204800000 }, "approval_disease_id": "c430a48a9cc04b12afd9da415bd5cc56", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125446-20180306" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "4ceb0eaafaa9457baa2ec09076cfd008" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1372204800000 }
[ "{\"name\":\"Rixubis\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Coagulation Factor IX (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Baxter Healthcare Corporation\",\"lang\":\"EN\"}", "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
23e48423a52a80020e59ea242eaae850
335,010
125506
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:41:50.000Z
2026-04-20T01:06:10.000Z
data@patsnap.com
admin@patsnap.com
{ "time_trust_code": 7, "time_ts": 1445299200000 }
[ "fb2274d1cf404e258803f0e3ff40cee2" ]
[ "e1974573a07c4c4e84dd1ceefc9f24f2" ]
[ "9249eff116f469bec1f88f12f24f6a97" ]
[ "9249eff116f469bec1f88f12f24f6a97" ]
null
59
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1445299200000 }, "approval_disease_id": "e1974573a07c4c4e84dd1ceefc9f24f2", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125506-20191002" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "fb2274d1cf404e258803f0e3ff40cee2" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1445299200000 }
[ "{\"name\":\"Coagadex\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Coagulation Factor X (Human)\",\"lang\":\"EN\"}", "{\"name\":\"Coagulation Factor X (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio Products Laboratory Limited\",\"lang\":\"EN\"}", "{\"name\":\"Bio Products Laboratory USA, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2422aa2858222a4e89a288e8d3a48220
322,352
103061
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:27:44.000Z
2026-04-18T01:04:50.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": -607737600000 }
[ "060c84bd5efd477883c886ff520e2516" ]
null
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
null
60
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, { ...
null
[ "060c84bd5efd477883c886ff520e2516" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -607737600000 }
null
[ "{\"name\":\"Animal Allergens, Standardized Cat Pelt\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK-Abello, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
24429d5234e38e9ad94e2a28e2da28ad
322,480
125773
1
ACTIVE
FDA_CBER
EN
2024-02-17T09:06:50.000Z
2026-04-20T01:06:51.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1708041600000 }
[ "64bd922d58e142408981b2de8a69f0ed" ]
[ "c1cc2528f29940fc95fd6bc37eb982d4" ]
[ "f2249b19b979aa8067e9cc6da77e3383" ]
[ "f2249b19b979aa8067e9cc6da77e3383" ]
null
61
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1708041600000 }, "approval_disease_id": "c1cc2528f29940fc95fd6bc37eb982d4", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125773-20240216" } ]
[ { "dosage_form": [ { "name": "Suspension", "normalized_id": "4d250073d7a54d71b5c3cbb005efc5a3" } ], "name": "Suspension; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "64bd922d58e142408981b2de8a69f0ed" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1708041600000 }
[ "{\"name\":\"AMTAGVI\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Lifileucel\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Iovance Biotherapeutics, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2452d2e442952d85aa08d85e2a309e02
334,915
125400
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:55:32.000Z
2026-04-20T01:06:31.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1331251200000 }
[ "e1acd30456554576b1bb8666bfeaa55f" ]
[ "2ccc8f5d48b643b49ad9b43692da2fad" ]
[ "51887f851077abb23b9ce943ec71c4a0" ]
[ "51887f851077abb23b9ce943ec71c4a0" ]
null
62
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1331251200000 }, "approval_disease_id": "2ccc8f5d48b643b49ad9b43692da2fad", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125400-20180220" }, { "approval_disease_id": "2ccc8f5d48b643b49ad9b43692da2fad...
[ { "dosage_form": [ { "name": "Cellular Sheet" } ], "name": "Cellular Sheet; Topical", "route": [ { "name": "Topical", "normalized_id": "e2f406237f8c4482aab66196088edc41" } ] } ]
null
[ "e1acd30456554576b1bb8666bfeaa55f" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1331251200000 }
[ "{\"name\":\"Gintuit\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Organogenesis, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Organogenesis Incorporated\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2482255055248e3825250828a84338dd
334,001
125109
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:35:41.000Z
2026-04-20T01:06:21.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1114992000000 }
[ "1c02b7b708804355bdde1ebe247e19a6" ]
[ "2afb4460671b4f2293b59b6200ec80e9", "2f0b9bcb2ec04863b26f144060ba3d29" ]
[ "278f22669a4efe54c15eeddeb79edf3a", "9c58a700f57923220e84515d26fc0168" ]
[ "278f22669a4efe54c15eeddeb79edf3a", "9c58a700f57923220e84515d26fc0168" ]
null
63
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1114992000000 }, "approval_disease_id": "2f0b9bcb2ec04863b26f144060ba3d29", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125109-20180305" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "1c02b7b708804355bdde1ebe247e19a6" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1114992000000 }
[ "{\"name\":\"Cnj-016\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Vaccinia Immune Globulin Intravenous (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Cangene Corp.\",\"lang\":\"EN\"}", "{\"name\":\"Emergent BioSolutions Canada Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
24929e502249a25439e555822eae2304
322,348
125004,125002,125001,125017
0
ACTIVE
FDA_CBER
EN
2022-03-12T07:40:15.000Z
2024-12-19T05:56:45.000Z
data@patsnap.com
chenghongyan@patsnap.com
null
null
null
[ "1b822c06b88c5ccd17cb89e3f76e12a7" ]
[ "1b822c06b88c5ccd17cb89e3f76e12a7" ]
null
64
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent, Ant-c (Monoclonal)\",\"lang\":\"EN\"}", "{\"name\":\"Blood Grouping Reagent, Anti-C (Monoclonal)\",\"lang\":\"EN\"}", "{\"name\":\"Blood Grouping Reagent, Anti-E (Monoclonal)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagents - Anti-C (Monoclonal), Anti-E (Monoclonal), Anti-e (Monoclonal), Anti-c (Monoclonal)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Micro Typing Systems, Inc.\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
24e85254de222a4a922a4038aa5e3292
334,327
103942
1
ACTIVE
FDA_CBER
EN
2022-09-14T09:19:51.000Z
2026-04-18T01:05:33.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 951350400000 }
[ "60c7e23692ce48f288677d7829b242d6" ]
null
[ "1edb14d720206752a16fb2c988f9245e" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
null
65
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] } ]
null
[ "60c7e23692ce48f288677d7829b242d6" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 951350400000 }
[ "{\"name\":\"Mycobax\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"BCG Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Sanofi Pasteur Limited\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
25094200aaaaae5228235829404eaad3
322,430
125685
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:36:55.000Z
2026-04-20T01:05:30.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1633651200000 }
[ "7ae51bd06a1748e0915bb7841e803d04" ]
[ "133287a5664c4f309dba3f266bd97767" ]
[ "ca66d2661dafdf2735d06ae038123df4", "2666d0d8cdb2b3dc15a38834ef2088ee" ]
[ "ca66d2661dafdf2735d06ae038123df4", "2666d0d8cdb2b3dc15a38834ef2088ee" ]
null
66
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1633651200000 }, "approval_disease_id": "133287a5664c4f309dba3f266bd97767", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125685-20211104" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "For Suspension", "normalized_id": "062e509891304aa1a68ff05cec686fd7" } ], "name": "For Suspension; Implantation", "route": [ { "name": "Implantation", "normalized_id": "fa8172db72ec4dc6803409ba5fdede3e" } ] }...
null
[ "7ae51bd06a1748e0915bb7841e803d04" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1633651200000 }
[ "{\"name\":\"Rethymic\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"allogeneic processed thymus tissue-agdc\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Enzyvant Therapeutics GmbH\",\"lang\":\"EN\"}", "{\"name\":\"Sumitomo Pharma Switzerland GmbH\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
25209d8e859ee98d52ad39a53008aaa8
334,601
103970
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:19.000Z
2026-04-18T01:05:23.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 686880000000 }
[ "a0af922466f444c8a41cf097c28fde1e" ]
null
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
null
67
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, ...
null
[ "a0af922466f444c8a41cf097c28fde1e" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 686880000000 }
[ "{\"name\":\"Pharmalgen\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Venoms, Mixed Vespid Venom Protein\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK - Abello A/S\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
252a5a4ea50a3228448ed500325de9e4
334,398
103112
1
ACTIVE
FDA_CBER
EN
2022-09-14T09:19:43.000Z
2026-04-18T01:04:53.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 20044800000 }
[ "7656c9eab70d452b87173969c7b0ecb7" ]
null
[ "73c1133fc93070f7a723b33ac0d3b16d" ]
[ "73c1133fc93070f7a723b33ac0d3b16d" ]
null
68
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "7656c9eab70d452b87173969c7b0ecb7" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 20044800000 }
[ "{\"name\":\"Proplex-T; Bebulin\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Factor IX Complex\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Baxalta US Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
253359de39e580889a25d9eea5a2e23e
322,487
102214
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:26:40.000Z
2026-04-18T01:04:56.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1248134400000 }
[ "b88c27a4b6724ccf8904d73b47f87c3b" ]
null
[ "120a7f68c33321cc79b6556a3842e1d9" ]
[ "120a7f68c33321cc79b6556a3842e1d9" ]
null
69
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "b88c27a4b6724ccf8904d73b47f87c3b" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1248134400000 }
null
[ "{\"name\":\"Pollens - Grasses, Bermuda Grass Cynodon dactylon\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allermed Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2548ae8d48ed2e959aea5280224ea002
334,296
125115
1
ACTIVE
FDA_CBER
EN
2022-09-14T09:20:06.000Z
2026-04-20T01:06:22.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1136764800000 }
[ "5b0b0cf69bd24f79a88b2725ec302189" ]
[ "03eb5d3e15c14dca9bf67d355a8d20be" ]
[ "e6ced78f036e804a7102f46703025f04" ]
[ "e6ced78f036e804a7102f46703025f04" ]
null
70
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1136764800000 }, "approval_disease_id": "03eb5d3e15c14dca9bf67d355a8d20be", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125115-20180226" }, { "approval_disease_id": "03eb5d3e15c14dca9bf67d355a8d20be...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Subcutaneous", "route": [ { "name": "Subcutaneous", "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" } ] } ]
null
[ "5b0b0cf69bd24f79a88b2725ec302189" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1136764800000 }
[ "{\"name\":\"Vivaglobin\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Immune Globulin Subcutaneous (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring GmbH\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
1
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
259aee0dee88e084908495020e32a22d
334,247
101140
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:57.000Z
2026-04-18T01:04:40.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -355017600000 }
[ "540f4efc5d6147e8949a6167e3085d69" ]
null
[ "ba285f52362d5707e4cbab569e6cde8c" ]
[ "ba285f52362d5707e4cbab569e6cde8c" ]
null
71
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "540f4efc5d6147e8949a6167e3085d69" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -355017600000 }
[ "{\"name\":\"Plasmanate\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Plasma Protein Fraction (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Grifols Therapeutics LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
25d00e025ee48aa2a52d504d209e52a0
334,892
101383
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:25:54.000Z
2026-04-18T01:05:02.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1248134400000 }
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
null
72
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, { ...
null
[ "dd47b6a135cf4276b52a4c5a38d6e479" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1248134400000 }
null
[ "{\"name\":\"Pollens - Grasses, Redtop Agrostis alba\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allergy Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
25e22a3a2aa544eae23a88ae5e489e25
334,140
102366
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:28:05.000Z
2026-04-18T01:04:31.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 206928000000 }
[ "3a3bb755e5e246ceb7755f7e8351d06a" ]
null
[ "fb0c93f2602d78e54f5cb1533d67c850" ]
[ "fb0c93f2602d78e54f5cb1533d67c850" ]
null
73
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "3a3bb755e5e246ceb7755f7e8351d06a" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 206928000000 }
[ "{\"name\":\"Alburx\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Albumin (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring AG\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
25e9a02359253829a22ea02ae02a822a
335,080
125533
1
ACTIVE
FDA_CBER
EN
2023-07-08T01:31:02.000Z
2026-04-20T01:06:00.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "47d732945490e7eb4bd4dc914f75228d" ]
[ "47d732945490e7eb4bd4dc914f75228d" ]
null
74
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Anti-D (Monoclonal Blend)(Formulated for Automated Testing)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagent, Anti-D (Monoclonal Blend)(Formulated for Automated Testing)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio-Rad Medical Diagnostics GmbH\",\"lang\":\"EN\"}" ]
null
null
null
1
BLA
null
null
null
282925d3485ae35d8d34889e8803dd54
322,543
103385
1
ACTIVE
FDA_CBER
EN
2023-07-08T01:36:51.000Z
2026-04-20T01:06:14.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "73cf2b8f828a3201a51e8a789e03d869" ]
[ "73cf2b8f828a3201a51e8a789e03d869" ]
null
75
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"HIVAB HIV-1/HIV-2 (rDNA) EIA\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Abbott Laboratories\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
282d28448a9a2aa855e292e4904a5a84
322,542
125100
1
ACTIVE
FDA_CBER
EN
2023-07-08T01:35:28.000Z
2026-04-20T01:04:50.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "b4904fbc444a6fbb10eadef3897c1df2" ]
[ "b4904fbc444a6fbb10eadef3897c1df2" ]
null
76
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"BioLife Plasma Services, L.P.\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
282e2259845229e58a8a9a82e3e3aeed
322,564
12503010
0
ACTIVE
FDA_CBER
EN
2022-03-12T08:04:53.000Z
2024-04-13T06:22:28.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "4d5a557c66947e16cf718f036e24def7" ]
[ "4d5a557c66947e16cf718f036e24def7" ]
null
77
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Genetic Systems HIV-1/HIV-2 Plus O EIA\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bio-Rad Laboratories\",\"lang\":\"EN\"}" ]
null
null
1
2
BLA
null
null
null
28523ea8ead88302e33282259eaae892
334,946
101066
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:26:58.000Z
2026-04-20T01:06:10.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 522460800000 }
[ "e78eeea0e4b544e9b6dcb47f5f43f29e" ]
[ "8b107203951e4ae9bfe9667fccbe8df9" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
null
78
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 522460800000 }, "approval_disease_id": "8b107203951e4ae9bfe9667fccbe8df9", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA101066-20190424" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "e78eeea0e4b544e9b6dcb47f5f43f29e" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 522460800000 }
[ "{\"name\":\"Recombivax HB\",\"lang\":\"EN\"}", "{\"name\":\"Recombivax, Recombivax Hb\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis B Vaccine (Recombinant)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Merck Co, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharp & Dohme LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
4
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
285859825238e20d45e3a088d3e8204a
322,355
125108
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:37:09.000Z
2026-04-20T01:06:23.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1125964800000 }
[ "0959221a3773474ba233685389dcc756" ]
[ "821434ed0db1485ab210aae70e6cd489", "9caefdc94002408ea7d794c6960e8695", "157f7a978dfd43f3b31de0cebedb99fa", "c81d389040894d6db4a0cda96e2f0d2f" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
[ "6a8c172f1efc649035845f94c31a9c1e" ]
null
79
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1125964800000 }, "approval_disease_id": "c81d389040894d6db4a0cda96e2f0d2f", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125108-20210416" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }...
null
[ "0959221a3773474ba233685389dcc756" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1677456000000 }
[ "{\"name\":\"Proquad\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Measles, Mumps, Rubella and Varicella Virus Vaccine Live\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Merck & Co, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharp & Dohme Corp.\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharp & Dohme LLC\",\"lang\":\"EN\"}", "{\"name\":\"Merck Sharpe & Dohme Corp\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
9
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
288a03e252403dee858d22a402eea202
335,051
125247
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:34:03.000Z
2026-04-20T01:06:12.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 1188172800000 }
[ "ffd2a918e2044f15b876d59073b6beb7" ]
[ "71d86eb1f39c4e509b8da8fe4343bdd3" ]
[ "955937fb0472058388672825abc7197a" ]
[ "955937fb0472058388672825abc7197a" ]
null
80
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1188172800000 }, "approval_disease_id": "71d86eb1f39c4e509b8da8fe4343bdd3", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125247-20180226" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Topical", "route": [ { "name": "Topical", "normalized_id": "e2f406237f8c4482aab66196088edc41" } ] }, { "d...
null
[ "ffd2a918e2044f15b876d59073b6beb7" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1253145600000 }
[ "{\"name\":\"Evithrom\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Thrombin, Topical (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Omrix Biopharmaceuticals Ltd\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
28a3a8e34ee8d539585528e43923a522
322,532
125567- 125573
0
ACTIVE
FDA_CBER
EN
2022-03-12T07:39:23.000Z
2024-04-13T06:21:01.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "9472fb2378c5276820bb3a479988861d" ]
[ "9472fb2378c5276820bb3a479988861d" ]
null
81
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Blood Grouping Reagent, Anti-Fya (Monoclonal) (IgG)\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Blood Grouping Reagents, Anti-Fya, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-P1\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Alba Bioscience Limited.\",\"lang\":\"EN\"}" ]
null
null
1
1
BLA
null
null
null
28a582828a2442822808aee2a3a89aa9
334,859
125363
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:07:19.000Z
2026-04-20T01:06:22.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1339632000000 }
[ "cf6f7442d99c4dce9435f50cb27a83c8" ]
[ "e3fc23ccb7c246a28010505f27ede647", "34fcc2e14284424e8069bdbbaa3a782c" ]
[ "eadc10deede4b8846c6aff09307f3ed1" ]
[ "eadc10deede4b8846c6aff09307f3ed1" ]
null
82
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1339632000000 }, "approval_disease_id": "34fcc2e14284424e8069bdbbaa3a782c", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125363-20180301" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "cf6f7442d99c4dce9435f50cb27a83c8" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1339632000000 }
[ "{\"name\":\"MENHIBRIX\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"GlaxoSmithKline Biologicals\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
5
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
28d859dd92a34885de49d28ea2ae4e93
322,366
101378
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:25:29.000Z
2026-04-18T01:04:56.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -1245801600000 }
[ "14f3c3e076d84585833e27cbc707bdf2" ]
null
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
[ "59750177e357c9b2fb8f41d5d9ca1f62" ]
null
83
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Percutaneous", "route": [ { "name": "Percutaneous", "normalized_id": "2232179efe2b48ee8f0ad48b0fc12557" } ] }, { ...
null
[ "14f3c3e076d84585833e27cbc707bdf2" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -1245801600000 }
null
[ "{\"name\":\"Insects (Whole Body), Mite Dermatophagoides pteronyssinus\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allergy Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
28d938a44a2a25ea8905a5e0550e9524
334,964
125594
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:55:12.000Z
2026-04-20T01:06:14.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1472688000000 }
[ "ee624eeef56f499c89fe43aadfe6d3d5" ]
[ "cd524b773fc6463a9a080ec578bf9c0d" ]
[ "a9c1f1f61dd4a9c167e5019b200e67b9" ]
[ "a9c1f1f61dd4a9c167e5019b200e67b9" ]
null
84
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1472688000000 }, "approval_disease_id": "cd524b773fc6463a9a080ec578bf9c0d", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125594-20191003" } ]
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "ee624eeef56f499c89fe43aadfe6d3d5" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1472688000000 }
[ "{\"name\":\"Clevecord\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"HPC, Cord Blood\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Cleveland Cord Blood Center\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
292208008da9248e99a3ea82d2ee4508
334,840
103957
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:29:13.000Z
2026-04-18T01:05:10.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 953251200000 }
[ "cb0e3c6ebf88458fb7886617476bd303" ]
null
[ "60b41da385616c7c85cabca2dabb8a89" ]
[ "60b41da385616c7c85cabca2dabb8a89" ]
null
85
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "cb0e3c6ebf88458fb7886617476bd303" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 953251200000 }
[ "{\"name\":\"Mononine\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Coagulation Factor IX (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"CSL Behring LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
292259d9325ea5382a28a4225280eea5
334,356
103754
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:21.000Z
2026-04-18T01:04:52.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": -607737600000 }
[ "6463505bcc99464fb6f606d265412e52" ]
null
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
[ "6c1f18f901be8a7c983c1dfe72ba1dde" ]
null
86
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "6463505bcc99464fb6f606d265412e52" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": -607737600000 }
[ "{\"name\":\"Histatrol\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Positive Skin Test Control-Histamine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"ALK-Abello, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2953d20a3d05e892e8520a3aa2a3aa50
334,278
103623
1
ACTIVE
FDA_CBER
EN
2022-09-14T09:19:09.000Z
2026-04-18T01:04:51.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 844214400000 }
[ "59a3b2500f654a4ea41f1ccaf30f9617" ]
null
[ "462096edf3de7b2de5a70c8fa9b70fa3" ]
[ "462096edf3de7b2de5a70c8fa9b70fa3" ]
null
87
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "59a3b2500f654a4ea41f1ccaf30f9617" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 844214400000 }
[ "{\"name\":\"COMVAX\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Merck Sharp & Dohme LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" } ]
null
null
1
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
298e2808a8adea322e25885333254258
322,433
103869
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:30:45.000Z
2026-04-20T01:06:11.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 927072000000 }
[ "7f9553d6807e46c0a7d309bfce18e802" ]
[ "309decc979cd4802a346ae247a6fede2", "8d0552935e5d4c3e908b569306b17a4e", "3a61bb332f264038b1612091521eaae7" ]
[ "bbc5fe68369d38a0223445bb4a014033" ]
[ "bbc5fe68369d38a0223445bb4a014033" ]
null
88
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 927072000000 }, "approval_disease_id": "309decc979cd4802a346ae247a6fede2", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103869-20180226" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "7f9553d6807e46c0a7d309bfce18e802" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 927072000000 }
[ "{\"name\":\"Thymoglobulin\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Anti-thymocyte Globulin (Rabbit)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Genzyme Corp\",\"lang\":\"EN\"}", "{\"name\":\"Genzyme Corporation\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
29980e53555d83d2eeaae5de4ae39eee
780,057
125789
1
ACTIVE
FDA_CBER
EN
2024-08-03T02:53:32.000Z
2026-04-20T01:06:31.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1722470400000 }
[ "29fbdd19354245a8a4f77e6822a9e11f" ]
[ "7032985f6c0b414f9993b7072c105fb4" ]
[ "e450843be747bfb8107aed04ee6c668d" ]
[ "e450843be747bfb8107aed04ee6c668d" ]
null
89
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1722556800000 }, "approval_disease_id": "7032985f6c0b414f9993b7072c105fb4", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125789-20240802" } ]
[ { "dosage_form": [ { "name": "Suspension", "normalized_id": "4d250073d7a54d71b5c3cbb005efc5a3" } ], "name": "Suspension; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "29fbdd19354245a8a4f77e6822a9e11f" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1722470400000 }
[ "{\"name\":\"tecelra\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"afamitresgene autoleucel\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Adaptimmune LLC\",\"lang\":\"EN\"}", "{\"name\":\"USWM CT, LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a2228a292d5a225959a0ad0ee8a2553
334,377
103931
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:31:39.000Z
2026-04-20T01:04:31.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 949622400000 }
[ "70a18410d60c469d8f95f551418ee843" ]
[ "26bdc387cad64dc985f00855d64a3d2d" ]
[ "bdb31a0ef372c1dafce734bc1c79601f", "eb4060e58f37d389f81cb5ed23029213" ]
[ "bdb31a0ef372c1dafce734bc1c79601f", "eb4060e58f37d389f81cb5ed23029213" ]
null
90
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 949622400000 }, "approval_disease_id": "26bdc387cad64dc985f00855d64a3d2d", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103931-20191216" }, { "action_date": { "time_trust_code": 7, "time_...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] }...
null
[ "70a18410d60c469d8f95f551418ee843" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 949622400000 }
[ "{\"name\":\"IMOVAX\",\"lang\":\"EN\"}", "{\"name\":\"Imovax Rabies\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Rabies Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Sanofi Pasteur\",\"lang\":\"EN\"}", "{\"name\":\"Sanofi Pasteur, SA\",\"lang\":\"EN\"}", "{\"name\":\"Sanofi Winthrop Industrie\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a22a3a9002285200923a4828e2353e8
322,394
103113
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:27:48.000Z
2026-04-18T01:04:41.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 132364800000 }
[ "3d4509aba3b94bf392fcea9b6bfd3686" ]
null
[ "120a7f68c33321cc79b6556a3842e1d9" ]
[ "120a7f68c33321cc79b6556a3842e1d9" ]
null
91
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "3d4509aba3b94bf392fcea9b6bfd3686" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 132364800000 }
null
[ "{\"name\":\"Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Allermed Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a243e28484d2a298224022354552522
334,432
125671
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:49:40.000Z
2026-04-18T01:06:41.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1550534400000 }
[ "8199f519b3d74806b6051c78b83619b7" ]
null
[ "663fbdfe9698d4aae0003f60ea4d98b4" ]
[ "663fbdfe9698d4aae0003f60ea4d98b4" ]
null
92
null
null
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "8199f519b3d74806b6051c78b83619b7" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1550534400000 }
[ "{\"name\":\"Esperoct\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic Factor (Recombinant), GlycoPEGylated-exei\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Novo Nordisk Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a2952e4450524342285345229344324
334,337
103914
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:36:56.000Z
2026-04-20T01:07:21.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 944697600000 }
[ "9029368e48264e5f8a88f73e60402348" ]
[ "c430a48a9cc04b12afd9da415bd5cc56", "d4d80c0d31134a8f9834eb7a8b8a9955", "2a8a3f6ab7ec4061858144283e7ce0ca" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
[ "1edb14d720206752a16fb2c988f9245e" ]
null
93
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 944697600000 }, "approval_disease_id": "c430a48a9cc04b12afd9da415bd5cc56", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA103914-20220215" }, { "action_date": { "time_trust_code": 7, "time_...
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intradermal", "route": [ { "name": "Intradermal", "normalized_id": "37fd743eeb354b3da77d8d64293868f7" } ] }, { "d...
null
[ "9029368e48264e5f8a88f73e60402348" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1572825600000 }
[ "{\"name\":\"Fluzone;Fluzone High-Dose;Fluzone Intradermal;Fluzone Quadrivalent;Fluzone High-Dose Quadrivalent;Fluzone Intradermal Quadrivalent;Fluzone Quadrivalent Southern Hemisphere\",\"lang\":\"EN\"}", "{\"name\":\"Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent\...
[ "{\"name\":\"Influenza Vaccine\",\"lang\":\"EN\"}", "{\"name\":\"Influenza Virus Vaccine\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Sanofi Pasteur Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a3589ed823024955480008ee89d9d8e
322,468
125661
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:56:26.000Z
2026-04-20T01:05:31.000Z
data@patsnap.com
chenghongyan@patsnap.com
{ "time_trust_code": 7, "time_ts": 1535500800000 }
[ "a5a3448968fe444199cbbb53c2e930b6" ]
[ "07d4cf59dafc4a35840dbf53e136394a", "71d86eb1f39c4e509b8da8fe4343bdd3" ]
[ "325e2f65e69a5b82d95b8c8faff3ed1c" ]
[ "325e2f65e69a5b82d95b8c8faff3ed1c" ]
null
94
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1535500800000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125661-20180925" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "a5a3448968fe444199cbbb53c2e930b6" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1733097600000 }
[ "{\"name\":\"Jivi\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Antihemophilic factor (recombinant), PEGylated-aucl\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bayer Healthcare, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Bayer HealthCare LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a522ae882e2aa55e3205a2595023a99
322,498
125351
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:49:28.000Z
2026-04-20T01:06:22.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1270425600000 }
[ "c9191c04a3d94c15aed1ac7f062b1929" ]
[ "71d86eb1f39c4e509b8da8fe4343bdd3" ]
[ "ad9ebc4611473d40ac1ff47a0ad83f55" ]
[ "ad9ebc4611473d40ac1ff47a0ad83f55" ]
null
95
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1270425600000 }, "approval_disease_id": "71d86eb1f39c4e509b8da8fe4343bdd3", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125351-20191003" } ]
[ { "dosage_form": [ { "name": "Patch", "normalized_id": "2b11811999ef4a4293b698b725bfe02f" } ], "name": "Patch; Topical", "route": [ { "name": "Topical", "normalized_id": "e2f406237f8c4482aab66196088edc41" } ] } ]
null
[ "c9191c04a3d94c15aed1ac7f062b1929" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1270425600000 }
[ "{\"name\":\"Tachosil\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Fibrin Sealant Patch\",\"lang\":\"EN\"}", "{\"name\":\"Fibrin Sealant Patch, Absorbable\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Corza Medical GmbH\",\"lang\":\"EN\"}", "{\"name\":\"Nycomed Danmark ApS\",\"lang\":\"EN\"}" ]
[ { "name": "Disc", "normalized_id": "66f5b04fecda493897939b23f6ea12cd" }, { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
2
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2a852d4080225295588eae8ae82e8259
334,499
125771
1
ACTIVE
FDA_CBER
EN
2023-03-02T12:41:41.000Z
2026-04-20T01:06:01.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1677024000000 }
[ "8f680ab936f440f69a414bbee284eb6f" ]
[ "07d4cf59dafc4a35840dbf53e136394a", "71d86eb1f39c4e509b8da8fe4343bdd3" ]
[ "311cab686bcc6adf35447547e80d8507" ]
[ "311cab686bcc6adf35447547e80d8507" ]
null
96
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1677024000000 }, "approval_disease_id": "07d4cf59dafc4a35840dbf53e136394a", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125771-20230222" } ]
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "8f680ab936f440f69a414bbee284eb6f" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1677024000000 }
[ "{\"name\":\"ALTUVIIIO\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Bioverativ Therapeutics, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Bioverativ Therapeutics Inc., a Sanofi Company\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
6
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2aae2edea9838ee50849002e28a52e44
334,272
125696
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:19:44.000Z
2026-04-20T01:15:11.000Z
data@patsnap.com
shimeihua@patsnap.com
{ "time_trust_code": 7, "time_ts": 1580428800000 }
[ "b412713b632b4421ae9f9d44ed7dfb6f" ]
[ "dbf67c6dedd9446c9ffd8a9904e8d4ea" ]
[ "0eadbae419b39df038ede0ce7d6bd7af" ]
[ "0eadbae419b39df038ede0ce7d6bd7af" ]
null
97
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1580428800000 }, "approval_disease_id": "dbf67c6dedd9446c9ffd8a9904e8d4ea", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125696-20200224" } ]
[ { "dosage_form": [ { "name": "Powder", "normalized_id": "6a9312b4bf874f6d987d05161e732c38" } ], "name": "Powder; Oral", "route": [ { "name": "Oral", "normalized_id": "9961b78a3a0d4085a0b8ace04df4a2f6" } ] } ]
null
[ "b412713b632b4421ae9f9d44ed7dfb6f" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1580428800000 }
[ "{\"name\":\"Palforzia\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Peanut (Arachis hypogaea) Allergen Powder-dnfp\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Aimmune Therapeutics, Inc.\",\"lang\":\"EN\"}", "{\"name\":\"Greer Laboratories, Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
1
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2d20e5828253424a25a82959e25e220e
335,160
125113
1
ACTIVE
FDA_CBER
EN
2022-03-12T08:02:39.000Z
2026-04-20T01:04:50.000Z
data@patsnap.com
data@patsnap.com
null
null
null
[ "8d3620846da94055be98c1ba276a673e" ]
[ "8d3620846da94055be98c1ba276a673e" ]
null
98
null
null
null
null
null
null
null
null
null
null
null
null
null
null
[ "{\"name\":\"Procleix Ultrio Assay\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Gen-Probe, Inc\",\"lang\":\"EN\"}" ]
null
null
1
3
BLA
null
null
null
2e02e48d5ae5892a50005dde285848d4
322,370
125267
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:38:16.000Z
2026-04-20T01:06:31.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 1223596800000 }
[ "1850bc27a9514c49bf320d126245a856" ]
[ "6e0b19fb626347a18144a6f986035dfc" ]
[ "4099573c333dcbc48d8f398aee392060", "b93ebb8fca54798f09b30d4420198b39" ]
[ "4099573c333dcbc48d8f398aee392060", "b93ebb8fca54798f09b30d4420198b39" ]
null
99
null
[ { "action_date": { "time_trust_code": 7, "time_ts": 1223596800000 }, "approval_disease_id": "6e0b19fb626347a18144a6f986035dfc", "market_status_id": "42d0efa0fd1a48aea4913755067bc043", "source": "BLA125267-20180717" }, { "action_date": { "time_trust_code": 7, "time...
[ { "dosage_form": [ { "name": "For Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "For Injection; Intravenous", "route": [ { "name": "Intravenous", "normalized_id": "1a7a6fdc93964e4bb987a68eb19d4a71" } ] } ]
null
[ "1850bc27a9514c49bf320d126245a856" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 1223596800000 }
[ "{\"name\":\"Cinryze\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"C1 Esterase Inhibitor (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Lev Pharmaceuticals, Inc\",\"lang\":\"EN\"}", "{\"name\":\"Lev Pharmaceuticals, Inc., License #1780\",\"lang\":\"EN\"}", "{\"name\":\"Takeda Pharmaceuticals U.S.A., Inc.\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
3
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }
2e23aa259a5248d822854052ae4ed09e
322,396
101146
1
ACTIVE
FDA_CBER
EN
2022-03-12T07:26:08.000Z
2026-04-18T01:04:30.000Z
data@patsnap.com
data@patsnap.com
{ "time_trust_code": 7, "time_ts": 243820800000 }
[ "3d99e68b05b14f4c8f69db7be9d1dad1" ]
null
[ "ba285f52362d5707e4cbab569e6cde8c" ]
[ "ba285f52362d5707e4cbab569e6cde8c" ]
null
100
null
null
[ { "dosage_form": [ { "name": "Injection", "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ], "name": "Injection; Intramuscular", "route": [ { "name": "Intramuscular", "normalized_id": "ffdad622a1da4c99b830db4a560aefbe" } ] } ]
null
[ "3d99e68b05b14f4c8f69db7be9d1dad1" ]
null
null
null
null
null
null
null
null
{ "time_trust_code": 7, "time_ts": 243820800000 }
[ "{\"name\":\"Bayhep B, Hyperhep B S/D\",\"lang\":\"EN\"}" ]
[ "{\"name\":\"Hepatitis B Immune Globulin (Human)\",\"lang\":\"EN\"}" ]
null
[ "{\"name\":\"Grifols Therapeutics LLC\",\"lang\":\"EN\"}" ]
[ { "name": "Rx", "normalized_id": "42d0efa0fd1a48aea4913755067bc043" } ]
null
null
null
BLA
null
null
{ "name": "351(a)", "normalized_id": "88b530ebcb4039828a261a3e631c9b2b" }