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
Skyrizi 761105 4 351(a) risankizumab-rzaa Injection Subcutaneous 180MG/1.2ML (150MG/ML) Single-Dose Cartridge 2022/09/23 AbbVie Inc. Rx Licensed N/A N/A
Skysona 125755 1 351(a) elivaldogene autotemcel Injection Intravenous 2-30 × 10^6 CELL/ML Bag 2022/09/16 Bluebird Bio Inc. Rx Licensed N/A N/A
Rolvedon 761148 1 351(a) eflapegrastim-xnst Injection Subcutaneous 13.2MG/0.6ML Pre-Filled Syringe 2022/09/09 Spectrum Pharmaceuticals, Inc. Rx Licensed N/A N/A
Daxxify 761127 1 351(a) daxibotulinumtoxinA-lanm For Injection Intramuscular 50UNITS Single-Dose Vial 2022/09/07 Revance Therapeutics, Inc. Rx Licensed N/A N/A
Daxxify 761127 2 351(a) daxibotulinumtoxinA-lanm For Injection Intramuscular 100UNITS Single-Dose Vial 2022/09/07 Revance Therapeutics, Inc. Rx Licensed N/A N/A
Stimufend 761173 1 351(k) Biosimilar pegfilgrastim-fpgk Injection Subcutaneous 6MG/0.6ML Pre-Filled Syringe 2022/09/01 Fresenius Kabi USA, LLC Rx Licensed pegfilgrastim-fpgk Neulasta
Spevigo 761244 1 351(a) spesolimab-sbzo Injection Intravenous 450MG/7.5ML (60MG/ML) Single-Dose Vial 2022/09/01 Boehringer Ingelheim Pharmaceuticals, Inc. Rx Licensed N/A N/A
Xenpozyme 761261 1 351(a) olipudase alfa-rpcp For Injection Intravenous 20MG Single-Dose Vial 2022/08/31 Genzyme Corporation Rx Licensed N/A N/A
Zynteglo 125717 1 351(a) betibeglogene autotemcel For Injection Intravenous 1.7-20 X 10^6CELL/ML Bag 2022/08/17 Bluebird Bio Inc. Rx Licensed N/A N/A
Hadlima 761059 4 351(k) Biosimilar adalimumab-bwwd Injection Subcutaneous 40MG/0.4ML Autoinjector 2022/08/15 Samsung Bioepis Co., Ltd. Rx Licensed adalimumab Humira
Hadlima 761059 5 351(k) Biosimilar adalimumab-bwwd Injection Subcutaneous 40MG/0.4ML Pre-Filled Syringe 2022/08/15 Samsung Bioepis Co., Ltd. Rx Licensed adalimumab Humira
Cimerli 761165 1 351(k) Interchangeable ranibizumab-eqrn Injection Intravitreal 10MG/ML (0.5MG/0.05ML) Single-Dose Vial 2022/08/02 Coherus BioSciences, Inc. Rx Licensed ranibizumab Lucentis
Cimerli 761165 2 351(k) Interchangeable ranibizumab-eqrn Injection Intravitreal 6MG/ML (0.3MG/0.05ML) Single-Dose Vial 2022/08/02 Coherus BioSciences, Inc. Rx Licensed ranibizumab Lucentis
Ultomiris 761108 4 351(a) ravulizumab-cwvz Injection Subcutaneous 245MG/3.5ML (70MG/ML) Single-Dose Cartridge 2022/06/22 Alexion Pharmaceuticals, Inc. Rx Licensed N/A N/A
Hadlima 761059 3 351(k) Biosimilar adalimumab-bwwd Injection Subcutaneous 40MG/0.8ML Single-Dose Vial 2022/06/17 Samsung Bioepis Co., Ltd. Rx Licensed adalimumab Humira
Skyrizi 761105 5 351(a) risankizumab-rzaa Injection Subcutaneous 360MG/2.4ML (150MG/ML) Single-Dose Cartridge 2022/06/16 AbbVie Inc. Rx Licensed N/A N/A
Skyrizi 761105 6 351(a) risankizumab-rzaa Injection Intravenous 600MG/10ML (60MG/ML) Single-Dose Vial 2022/06/16 AbbVie Inc. Rx Licensed N/A N/A
PRIORIX 125748 1 351(a) Measles, Mumps and Rubella Virus Vaccine Live For Injection Subcutaneous 3.4, 4.2 and 3.3LOG10 Single-Dose Vial 2022/06/03 GlaxoSmithKline Biologicals Rx Licensed N/A N/A
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
当前数据更新日期:2022年12月01日,更多信息请点击此处查询美国FDA药品数据库

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