美国FDA生物制品紫皮书数据库
（U.S. FDA Purple Book: Database of Licensed Biological Products）
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数据记录共 2160 条，共 108 页，当前第 57 页
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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
Apidra 021629 003 351(a) insulin glulisine Injection Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector 2009/02/24 Sanofi-Aventis U.S. LLC Rx Licensed N/A N/A
Atryn 125284 001 351(a) Antithrombin (Recombinant) For Injection Intravenous 1750IU Single-Dose Vial 2009/02/06 rEVO Biologics, Inc. Disc Voluntarily Revoked N/A
Riastap 125317 001 351(a) Fibrinogen Concentrate (Human) For Injection Intravenous 900-1300MG Single-Dose Vial 2009/01/16 CSL Behring GmbH Rx Licensed N/A
Cinryze 125267 001 351(a) C1 Esterase Inhibitor (Human) For Injection Intravenous 500U Single-Dose Vial 2008/10/10 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
Novolog Mix 50/50 021810 001 351(a) insulin aspart protamine and insulin aspart Injectable Suspension Subcutaneous 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) Multi-Dose Cartridge 2008/08/26 Novo Nordisk Inc. Disc Voluntarily Revoked N/A N/A
Novolog Mix 50/50 021810 002 351(a) insulin aspart protamine and insulin aspart Injectable Suspension Subcutaneous 150UNITS/3ML (50UNITS/ML); 150UNITS/3ML (50UNITS/ML) Autoinjector 2008/08/26 Novo Nordisk Inc. Disc Voluntarily Revoked N/A N/A
Omnitrope 021426 004 351(a) somatropin Injection Subcutaneous 10MG/1.5ML Multi-Dose Cartridge 2008/08/25 Sandoz Inc. Rx Licensed N/A N/A
Nplate 125268 001 351(a) romiplostim For Injection Subcutaneous 250MCG Single-Dose Vial 2008/08/22 Amgen Inc. Rx Licensed N/A N/A
Nplate 125268 002 351(a) romiplostim For Injection Subcutaneous 500MCG Single-Dose Vial 2008/08/22 Amgen Inc. Rx Licensed N/A N/A
Kinrix 125260 001 351(a) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Injection Intramuscular 0.5ML Single-Dose Vial 2008/06/24 GlaxoSmithKline Biologicals Rx Licensed N/A
Pentacel 125145 001 351(a) Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Injection Intramuscular 0.5ML Single-Dose Vial 2008/06/20 Sanofi Pasteur Limited Rx Licensed N/A
PegIntron/ Rebetol Combo Pack 125196 001 351(a) peginterferon alfa-2b and ribavirin 50MCG/0.5ML & 200MG 2008/06/13 Schering Corporation a subsidiary of Merck & Co., Inc. Disc Voluntarily Revoked N/A N/A
PegIntron/ Rebetol Combo Pack 125196 002 351(a) peginterferon alfa-2b and ribavirin 80MCG/0.5ML & 200MG 2008/06/13 Schering Corporation a subsidiary of Merck & Co., Inc. Disc Voluntarily Revoked N/A N/A
PegIntron/ Rebetol Combo Pack 125196 003 351(a) peginterferon alfa-2b and ribavirin 120MCG/0.5ML & 200MG 2008/06/13 Schering Corporation a subsidiary of Merck & Co., Inc. Disc Voluntarily Revoked N/A N/A
PegIntron/ Rebetol Combo Pack 125196 004 351(a) peginterferon alfa-2b and ribavirin 150MCG/0.5ML & 200MG 2008/06/13 Schering Corporation a subsidiary of Merck & Co., Inc. Disc Voluntarily Revoked N/A N/A
Recothrom 125248 002 351(a) Thrombin topical (Recombinant) For Solution Topical 20000IU Single-Dose Vial 2008/05/23 Baxter Healthcare Corporation Rx Licensed N/A
Novoseven, Novoseven Rt 103665 004 351(a) Coagulation Factor VIIa (Recombinant) For Injection Intravenous 5.0MG Single-Dose Vial 2008/05/09 Novo Nordisk Inc. Rx Licensed N/A
Novoseven, Novoseven Rt 103665 005 351(a) Coagulation Factor VIIa (Recombinant) For Injection Intravenous 1.0MG Single-Dose Vial 2008/05/09 Novo Nordisk Inc. Rx Licensed N/A
Novoseven, Novoseven Rt 103665 006 351(a) Coagulation Factor VIIa (Recombinant) For Injection Intravenous 2.0MG Single-Dose Vial 2008/05/09 Novo Nordisk Inc. Rx Licensed N/A
Cimzia 125160 001 351(a) certolizumab pegol For Injection Subcutaneous 200MG Single-Dose Vial 2008/04/22 UCB, Inc. Rx Licensed N/A N/A
当前数据更新日期：2026年02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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