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
Trazimera 761081 002 351(k) Biosimilar trastuzumab-qyyp For Injection Intravenous 150MG Single-Dose Vial 2020/11/30 Pfizer Ireland Pharmaceuticals Rx Licensed trastuzumab Herceptin
Danyelza 761171 001 351(a) naxitamab-gqgk Injection Intravenous 40MG/10ML (4MG/ML) Single-Dose Vial 2020/11/25 Y-mABs Therapeutics, Inc Rx Licensed
Inmazeb 761169 001 351(a) atoltivimab, maftivimab, and odesivimab-ebgn Injection Intravenous 241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML) Single-Dose Vial 2020/10/14 Regeneron Pharmaceuticals, Inc. Rx Licensed
Ultomiris 761108 002 351(a) ravulizumab-cwvz Injection Intravenous 300MG/3ML (100MG/ML) Single-Dose Vial 2020/10/09 Alexion Pharmaceuticals, Inc. Rx Licensed
Ultomiris 761108 003 351(a) ravulizumab-cwvz Injection Intravenous 1100MG/11ML (100MG/ML) Single-Dose Vial 2020/10/09 Alexion Pharmaceuticals, Inc. Rx Licensed
Polivy 761121 002 351(a) polatuzumab vedotin-piiq For Injection Intravenous 30MG Single-Dose Vial 2020/09/18 Genentech, Inc. Rx Licensed
Trulicity 125469 005 351(a) dulaglutide Injection Subcutaneous 3MG/0.5ML Autoinjector 2020/09/04 Eli Lilly and Company Rx Licensed
Trulicity 125469 006 351(a) dulaglutide Injection Subcutaneous 4.5MG/0.5ML Autoinjector 2020/09/04 Eli Lilly and Company Rx Licensed
Sogroya 761156 001 351(a) somapacitan-beco Injection Subcutaneous 10MG/1.5ML (6.7MG/ML) Autoinjector 2020/08/28 Novo Nordisk Inc. Rx Licensed
Kesimpta 125326 003 351(a) ofatumumab Injection Subcutaneous 20MG/0.4ML Autoinjector 2020/08/20 Novartis Pharmaceuticals Corporation Rx Licensed
Kesimpta 125326 004 351(a) ofatumumab Injection Subcutaneous 20MG/0.4ML Pre-Filled Syringe 2020/08/20 Novartis Pharmaceuticals Corporation Rx Licensed
Enspryng 761149 001 351(a) satralizumab-mwge Injection Subcutaneous 120MG/ML Pre-Filled Syringe 2020/08/14 Genentech, Inc. Rx Licensed
Blenrep 761158 001 351(a) belantamab mafodotin-blmf For Injection Intravenous 100MG Single-Dose Vial 2020/08/05 GlaxoSmithKline Intellectual Property Development Ltd. England Rx Licensed
Monjuvi 761163 001 351(a) tafasitamab-cxix For Injection Intravenous 200MG Single-Dose Vial 2020/07/31 MorphoSys US Inc. Rx Licensed
Tecartus 125703 001 351(a) Brexucabtagene Autoleucel For Injection Intravenous 2x10^6 CAR-positive viable T cells per kg body weight Bag 2020/07/24 Kite Pharma Inc. Rx Licensed
Qwo 761146 001 351(a) collagenase clostridium histolyticum-aaes For Injection Subcutaneous .92MG Single-Dose Vial 2020/07/06 Endo Global Aesthetics Limited Rx Licensed
Qwo 761146 002 351(a) collagenase clostridium histolyticum-aaes For Injection Subcutaneous 1.84MG Single-Dose Vial 2020/07/06 Endo Global Aesthetics Limited Rx Licensed
Hulio 761154 001 351(k) Biosimilar adalimumab-fkjp Injection Subcutaneous 40MG/0.8ML Autoinjector 2020/07/06 Mylan Pharmaceuticals Inc. Rx Licensed adalimumab Humira
Hulio 761154 002 351(k) Biosimilar adalimumab-fkjp Injection Subcutaneous 40MG/0.8ML Pre-Filled Syringe 2020/07/06 Mylan Pharmaceuticals Inc. Rx Licensed adalimumab Humira
Hulio 761154 003 351(k) Biosimilar adalimumab-fkjp Injection Subcutaneous 20MG/0.4ML Pre-Filled Syringe 2020/07/06 Mylan Pharmaceuticals Inc. Rx Licensed adalimumab Humira
当前数据更新日期:2021年01月06日,更多信息请点击此处查询美国FDA药品数据库

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