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
Evkeeza 761181 001 351(a) evinacumab-dgnb Injection Intravenous 345MG/2.3ML (150MG/ML) Single-Dose Vial 2021/02/11 Regeneron Pharmaceuticals, Inc. Rx Licensed
Evkeeza 761181 002 351(a) evinacumab-dgnb Injection Intravenous 1,200MG/8ML (150MG/ML) Single-Dose Vial 2021/02/11 Regeneron Pharmaceuticals, Inc. Rx Licensed
Breyanzi 125714 001 351(a) lisocabtagene maraleucel Injection Intravenous 4.6ML/VIAL Single-Dose Vial 2021/02/05 Juno Therapeutics, a Celgene Company Rx Licensed
Vaxchora 125597 002 351(a) Cholera Vaccine Live Oral For Suspension Oral 50ML Packet 2020/12/23 Emergent Travel Health, Inc. Rx Licensed
Vaxchora 125597 003 351(a) Cholera Vaccine Live Oral For Suspension Oral 100ML Packet 2020/12/23 Emergent Travel Health, Inc. Rx Licensed
Ebanga 761172 001 351(a) ansuvimab-zykl For Injection Intravenous 400MG Single-Dose Vial 2020/12/21 Ridgeback Biotherapeutics Rx Licensed
Riabni 761140 001 351(k) Biosimilar rituximab-arrx Injection Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial 2020/12/17 Amgen, Inc. Rx Licensed rituximab Rituxan
Riabni 761140 002 351(k) Biosimilar rituximab-arrx Injection Intravenous 500MG/50ML (10MG/ML) Single-Dose Vial 2020/12/17 Amgen, Inc. Rx Licensed rituximab Rituxan
Margenza 761150 001 351(a) margetuximab-cmkb Injection Intravenous 250MG/10ML (25MG/ML) Single-Dose Vial 2020/12/16 MacroGenics Inc. Rx Licensed
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
当前数据更新日期:2021年04月10日,更多信息请点击此处查询美国FDA药品数据库

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