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
Starjemza 761419 001 351(k) Interchangeable ustekinumab-hmny Injection Subcutaneous 45MG/0.5ML Pre-Filled Syringe 2025/05/22 Bio-Thera Solutions, Ltd. Rx Licensed ustekinumab Stelara
Starjemza 761419 002 351(k) Interchangeable ustekinumab-hmny Injection Subcutaneous 90MG/ML Pre-Filled Syringe 2025/05/22 Bio-Thera Solutions, Ltd. Rx Licensed ustekinumab Stelara
Starjemza 761419 003 351(k) Interchangeable ustekinumab-hmny Injection Subcutaneous 45MG/0.5ML Single-Dose Vial 2025/05/22 Bio-Thera Solutions, Ltd. Rx Licensed ustekinumab Stelara
Starjemza 761419 004 351(k) Interchangeable ustekinumab-hmny Injection Intravenous 130MG/26ML (5MG/ML) Single-Dose Vial 2025/05/22 Bio-Thera Solutions, Ltd. Rx Licensed ustekinumab Stelara
NUVAXOVID 125817 001 351(a) COVID-19 Vaccine, Adjuvanted Injection Intramuscular 5UG Pre-Filled Syringe 2025/05/16 Novavax, Inc. Rx Licensed
Emrelis 761384 001 351(a) telisotuzumab vedotin-tllv Injection Intravenous 20MG Single-Dose Vial 2025/05/14 AbbVie Inc. Rx Licensed
Emrelis 761384 002 351(a) telisotuzumab vedotin-tllv Injection Intravenous 100MG Single-Dose Vial 2025/05/14 AbbVie Inc. Rx Licensed
Humalog 205747 002 351(a) insulin lispro Injection Subcutaneous 600UNITS/3ML (200UNITS/ML) Autoinjector 2025/05/07 Eli Lilly and Company Rx Licensed
Imaavy 761430 001 351(a) nipocalimab-aahu Injection Intravenous 300MG/1.62ML (185MG/ML) Single-Dose Vial 2025/04/29 Janssen Biotech, Inc. Rx Licensed
Imaavy 761430 002 351(a) nipocalimab-aahu Injection Intravenous 1,200MG/6.5ML (185MG/ML) Single-Dose Vial 2025/04/29 Janssen Biotech, Inc. Rx Licensed
zevaskyn 125807 001 351(a) Prademagene zamikeracel Cellular Sheet Topical 41.25CM^2 Tray & Lid 2025/04/28 Abeona Therapeutics Inc. Rx Licensed
N/A 761258 001 351(a) penpulimab-kcqx Injection Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial 2025/04/23 Akeso Biopharma Co., Ltd. Rx Licensed
Vyvgart Hytrulo 761304 002 351(a) efgartigimod alfa and hyaluronidase-qvfc Injection Subcutaneous 1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML) Pre-Filled Syringe 2025/04/10 Argenx BV Rx Licensed
Jobevne 761175 001 351(k) Biosimilar bevacizumab-nwgd Injection Intravenous 100MG/4ML (25MG/ML) Single-Dose Vial 2025/04/09 Biocon Biologics Inc. Rx Licensed bevacizumab Avastin
Jobevne 761175 002 351(k) Biosimilar bevacizumab-nwgd Injection Intravenous 400MG/16ML (25MG/ML) Single-Dose Vial 2025/04/09 Biocon Biologics Inc. Rx Licensed bevacizumab Avastin
Jynneos 125678 002 351(a) Smallpox and Mpox Vaccine, Live, Non-replicating For Injection Subcutaneous 0.5-3.95 X 10E8 INF. U/.5ML Single-Dose Vial 2025/03/21 Bavarian Nordic A/S Rx Licensed
Otulfi 761379 004 351(k) Interchangeable ustekinumab-aauz Injection Subcutaneous 45MG/0.5ML Single-Dose Vial 2025/03/21 Fresenius Kabi USA, LLC Rx Licensed ustekinumab Stelara
Tyenne 761449 001 351(k) Biosimilar tocilizumab-aazg Injection Subcutaneous 162MG/0.9ML Pre-Filled Syringe 2025/03/14 Fresenius Kabi USA, LLC Rx Licensed tocilizumab Actemra
Tyenne 761449 002 351(k) Biosimilar tocilizumab-aazg Injection Subcutaneous 162MG/0.9ML Autoinjector 2025/03/14 Fresenius Kabi USA, LLC Rx Licensed tocilizumab Actemra
Omlyclo 761399 001 351(k) Interchangeable omalizumab-igec Injection Subcutaneous 75MG/0.5ML Pre-Filled Syringe 2025/03/07 CELLTRION, Inc. Rx Licensed omalizumab Xolair
当前数据更新日期:2025年07月09日,更多信息请点击此处查询美国FDA药品数据库

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