美国FDA生物制品紫皮书数据库
(U.S. FDA Purple Book: Database of Licensed Biological Products)
商品名 申请号 产品号 BLA类型 非专利名称 剂型 给药途径 规格/剂量 产品形式 批准日期 申请人 市场状态 许可证状态 参考产品非专利名称 参考产品专利名称
Beovu 761125 2 351(a) brolucizumab-dbll Injection Intravitreal 6MG/0.05ML Pre-Filled Syringe 2022/05/27 Novartis Pharmaceuticals Corporation Rx Licensed N/A N/A
Fylnetra 761084 1 351(k) Biosimilar pegfilgrastim-pbbk Injection Subcutaneous 6MG/0.6ML Pre-Filled Syringe 2022/05/26 Kashiv BioSciences, LLC Rx Licensed pegfilgrastim Neulasta
Sucraid 20772 2 351(a) sacrosidase Solution For Oral Oral 17,000IU/2ML (8,500IU/ML) 2022/05/25 QOL Medical, LLC Rx Licensed N/A N/A
Alymsys 761231 1 351(k) Biosimilar bevacizumab-maly Injection Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial 2022/04/13 Amneal Pharmaceuticals LLC Rx Licensed bevacizumab Avastin
Alymsys 761231 2 351(k) Biosimilar bevacizumab-maly Injection Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial 2022/04/13 Amneal Pharmaceuticals LLC Rx Licensed bevacizumab Avastin
Hyrimoz 761071 3 351(k) Biosimilar adalimumab-adaz Injection Subcutaneous 10MG/0.2ML Pre-Filled Syringe 2022/03/28 Sandoz Inc. Rx Licensed adalimumab Humira
Opdualag 761234 1 351(a) nivolumab and relatlimab-rmbw Injection Intravenous 240MG, 80MG/20ML (12MG, 4MG/ML) Single-Dose Vial 2022/03/18 Bristol-Myers Squibb Company Rx Licensed N/A N/A
Cyltezo 761058 3 351(k) Interchangeable adalimumab-adbm Injection Subcutaneous 10MG/0.2ML Pre-Filled Syringe 2022/03/18 Boehringer Ingelheim Pharmaceuticals, Inc. Rx Licensed adalimumab Humira
Carvykti 125746 1 351(a) ciltacabtagene autoleucel For Injection Intravenous 0.5 to 1.0×10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1×10^8 CAR-positive viable T cells in one infusion Bag 2022/02/28 Janssen Biotech, Inc. Rx Licensed N/A N/A
Releuko 761082 1 351(k) Biosimilar filgrastim-ayow Injection Intravenous, Subcutaneous 300MCG/ML Single-Dose Vial 2022/02/25 Kashiv BioSciences, LLC Rx Licensed filgrastim Neupogen
Releuko 761082 2 351(k) Biosimilar filgrastim-ayow Injection Intravenous, Subcutaneous 480MCG/1.6ML Single-Dose Vial 2022/02/25 Kashiv BioSciences, LLC Rx Licensed filgrastim Neupogen
Releuko 761082 3 351(k) Biosimilar filgrastim-ayow Injection Intravenous, Subcutaneous 300MCG/0.5ML Pre-Filled Syringe 2022/02/25 Kashiv BioSciences, LLC Rx Licensed filgrastim Neupogen
Releuko 761082 4 351(k) Biosimilar filgrastim-ayow Injection Intravenous, Subcutaneous 480MCG/0.8ML Pre-Filled Syringe 2022/02/25 Kashiv BioSciences, LLC Rx Licensed filgrastim Neupogen
Enjaymo 761164 1 351(a) sutimlimab-jome Injection Intravenous 1,100MG/22ML (50MG/ML) Single-Dose Vial 2022/02/04 Bioverativ Therapeutics, Inc. Rx Licensed N/A N/A
Spikevax 125752 1 351(a) COVID-19 Vaccine, mRNA Injection Intramuscular 100UG Multi-Dose Vial 2022/01/31 ModernaTX, Inc. Rx Licensed N/A N/A
Vabysmo 761235 1 351(a) faricimab-svoa Injection Intravitreal 120MG/ML Single-Dose Vial 2022/01/28 Genentech, Inc. Rx Licensed N/A N/A
Kimmtrak 761228 1 351(a) tebentafusp-tebn Injection Intravenous 100MCG/0.5ML Single-Dose Vial 2022/01/25 Immunocore Limited Rx Licensed N/A N/A
Nucala 125526 4 351(a) mepolizumab Injection Subcutaneous 40MG/0.4ML Pre-Filled Syringe 2022/01/22 GlaxoSmithKline LLC Rx Licensed N/A N/A
Nucala 761122 4 351(a) mepolizumab Injection Subcutaneous 40MG/0.4ML Pre-Filled Syringe 2022/01/22 GlaxoSmithKline LLC Rx Licensed N/A N/A
Adbry 761180 1 351(a) tralokinumab-ldrm Injection Subcutaneous 150MG/ML Pre-Filled Syringe 2021/12/27 LEO Pharma A/S Rx Licensed N/A N/A
当前数据更新日期:2022年06月30日,更多信息请点击此处查询美国FDA药品数据库

数据库说明:

©2006-2022 DrugFuture->U.S. FDA Purple Book