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 2130 条，共 107 页，当前第 24 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
Lyumjev 761109 004 351(a) insulin lispro-aabc Injection Intravenous, Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector 2020/06/15 Eli Lilly and Company Rx Licensed N/A N/A
Lyumjev 761109 005 351(a) insulin lispro-aabc Injection Intravenous, Subcutaneous 300UNITS/3ML (100UNITS/ML) Multi-Dose Cartridge 2020/06/15 Eli Lilly and Company Disc Licensed N/A N/A
Lyumjev 761109 006 351(a) insulin lispro-aabc Injection Intravenous, Subcutaneous 600UNITS/3ML (200UNITS/ML) Autoinjector 2020/06/15 Eli Lilly and Company Rx Licensed N/A N/A
Semglee 210605 001 351(a) insulin glargine Injection Subcutaneous 1,000UNITS/10ML (100 UNITS/ML) Multi-Dose Vial 2020/06/11 Mylan Pharmaceuticals Inc. Disc Voluntarily Revoked N/A N/A
Semglee 210605 002 351(a) insulin glargine Injection Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector 2020/06/11 Mylan Pharmaceuticals Inc. Disc Voluntarily Revoked N/A N/A
Uplizna 761142 001 351(a) inebilizumab-cdon Injection Intravenous 100MG/10ML (10MG/ML) Single-Dose Vial 2020/06/11 Horizon Therapeutics Ireland DAC Rx Licensed N/A N/A
Nyvepria 761111 001 351(k) Biosimilar pegfilgrastim-apgf Injection Subcutaneous 6MG/0.6ML Pre-Filled Syringe 2020/06/10 Hospira Inc., a Pfizer Company Rx Licensed pegfilgrastim Neulasta
Darzalex Faspro 761145 001 351(a) daratumumab and hyaluronidase-fihj Injection Subcutaneous 1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML) Single-Dose Vial 2020/05/01 Janssen Biotech, Inc. Rx Licensed N/A N/A
Menquadfi 125701 001 351(a) Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Injection Intramuscular 0.5ML Single-Dose Vial 2020/04/23 Sanofi Pasteur Inc. Rx Licensed
Trodelvy 761115 001 351(a) sacituzumab govitecan-hziy For Injection Intravenous 180MG Single-Dose Vial 2020/04/22 Gilead Sciences, Inc. Rx Licensed N/A N/A
Sevenfact 125641 001 351(a) coagulation factor VIIa (recombinant)-jncw Injection Intravenous 1MG Single-Dose Vial 2020/04/01 Laboratoire Francais du Fractionnement et des Biotechnologies S.A. Rx Licensed
Sevenfact 125641 002 351(a) coagulation factor VIIa (recombinant)-jncw Injection Intravenous 5MG Single-Dose Vial 2020/04/01 Laboratoire Francais du Fractionnement et des Biotechnologies S.A. Rx Licensed
Pulmotech MAA 210089 001 351(a) kit for the preparation of technetium Tc-99m albumin aggregated For Injectable Suspension Intravenous, Intraperitoneal 2MG Multi-Dose Vial 2020/03/20 Cis Bio International Rx Licensed N/A N/A
Ontruzant 761100 002 351(k) Biosimilar trastuzumab-dttb For Injection Intravenous 420MG Multi-Dose Vial 2020/03/20 Samsung Bioepis Co., Ltd. Rx Licensed trastuzumab Herceptin
prolastin,prolastin-c,prolastin-c liquid 103174 004 351(a) Alpha-1-Proteinase Inhibitor (Human) Injection Intravenous 4000MG/80ML Single-Dose Vial 2020/03/05 Grifols Therapeutics LLC Rx Licensed N/A
prolastin,prolastin-c,prolastin-c liquid 103174 005 351(a) Alpha-1-Proteinase Inhibitor (Human) Injection Intravenous 500MG/10ML Single-Dose Vial 2020/03/05 Grifols Therapeutics LLC Rx Licensed N/A
Enbrel 103795 007 351(a) etanercept Injection Subcutaneous 25MG/0.5ML Single-Dose Vial 2020/03/05 Immunex Corporation Rx Licensed N/A N/A
Sarclisa 761113 001 351(a) isatuximab-irfc Injection Intravenous 100MG/5ML (20MG/ML) Single-Dose Vial 2020/03/02 Sanofi-Aventis U.S. LLC Rx Licensed N/A N/A
Sarclisa 761113 002 351(a) isatuximab-irfc Injection Intravenous 500MG/25ML (20MG/ML) Single-Dose Vial 2020/03/02 Sanofi-Aventis U.S. LLC Rx Licensed N/A N/A
Fluad,Fluad Quadrivalent 125510 002 351(a) Influenza Vaccine, Adjuvanted Injection Intramuscular 60UG/.5ML Pre-Filled Syringe 2020/02/21 Seqirus Inc. Rx Licensed
当前数据更新日期：2025年12月18日，更多信息请点击此处查询美国FDA药品数据库

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