美国FDA生物制品紫皮书数据库
（U.S. FDA Purple Book: Database of Licensed Biological Products）
请输入需要查询的英文药品商品名称，非专利名称，申请号
*Search by proprietary (brand) name,nonproprietary name,BLA application number.
高级搜索
数据记录共 2130 条，共 107 页，当前第 85 页
可点击列名称排序
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
Recombivax, Recombivax Hb 101066 002 351(a) Hepatitis B Vaccine (Recombinant) Injection Intramuscular 40UG/ML Single-Dose Vial 1986/07/23 Merck Sharp & Dohme LLC Rx Licensed N/A
Recombivax, Recombivax Hb 101066 003 351(a) Hepatitis B Vaccine (Recombinant) Injection Intramuscular 10UG/ML Single-Dose Vial 1986/07/23 Merck Sharp & Dohme LLC Rx Licensed N/A
Intron A 103132 001 351(a) interferon alfa-2b For Injection Intramuscular, Intravenous, Subcutaneous 3MIU Single-Dose Vial 1986/06/04 Merck Sharp & Dohme LLC Disc Voluntarily Revoked N/A N/A
Intron A 103132 002 351(a) interferon alfa-2b For Injection Intramuscular, Intravenous, Subcutaneous 5MIU Single-Dose Vial 1986/06/04 Merck Sharp & Dohme LLC Disc Voluntarily Revoked N/A N/A
Intron A 103132 003 351(a) interferon alfa-2b For Injection Subcutaneous, Intravenous, Intralesional, Intramuscular 10MIU Single-Dose Vial 1986/06/04 Merck Sharp & Dohme LLC Disc Voluntarily Revoked N/A N/A
Intron A 103132 004 351(a) interferon alfa-2b For Injection Intramuscular, Intravenous, Subcutaneous 25MIU Multi-Dose Vial 1986/06/04 Merck Sharp & Dohme LLC Disc Voluntarily Revoked N/A N/A
Roferon-A 103145 001 351(a) interferon alfa-2a For Injection Subcutaneous 3MIU/0.5ML Pre-Filled Syringe 1986/06/04 Hoffmann-La Roche Inc. Disc Voluntarily Revoked N/A N/A
Digibind 103141 001 351(a) Digoxin Immune Fab (Ovine) For Injection Intravenous 38MG Single-Dose Vial 1986/04/22 Wellcome Foundation Limited Wellcome Research Laboratories Disc Voluntarily Revoked N/A
Gammagard, Gammagard S/D, Iveegam 103133 001 351(a) Immune Globulin Intravenous (Human) For Injection Intravenous 0.5G Single-Use Bottle 1986/02/18 Takeda Pharmaceuticals U.S.A., Inc. Disc Licensed N/A
Gammagard, Gammagard S/D, Iveegam 103133 002 351(a) Immune Globulin Intravenous (Human) For Injection Intravenous 1000MG Single-Use Bottle 1986/02/18 Takeda Pharmaceuticals U.S.A., Inc. Disc Licensed N/A
Gammagard, Gammagard S/D, Iveegam 103133 003 351(a) Immune Globulin Intravenous (Human) For Injection Intravenous 2500MG Single-Use Bottle 1986/02/18 Takeda Pharmaceuticals U.S.A., Inc. Disc Licensed N/A
Gammagard, Gammagard S/D, Iveegam 103133 004 351(a) Immune Globulin Intravenous (Human) For Injection Intravenous 500MG Single-Use Bottle 1986/02/18 Takeda Pharmaceuticals U.S.A., Inc. Disc Licensed N/A
Gammagard, Gammagard S/D, Iveegam 103133 005 351(a) Immune Globulin Intravenous (Human) For Injection Intravenous 5000MG Single-Use Bottle 1986/02/18 Takeda Pharmaceuticals U.S.A., Inc. Disc Licensed N/A
Thrombin-Jmi, Thrombocoll 102865 001 351(a) Thrombin, Topical (Bovine) Powder Topical 20,000IU Vial 1986/02/03 GenTrac, Inc. Rx Licensed N/A
Pergonal 017646 002 351(a) menotropins For Injection Subcutaneous, Intramuscular 150IU Single-Dose Vial 1985/05/20 EMD Serono, Inc. Disc Licensed N/A N/A
Novarel 017016 010 351(a) chorionic gonadotropin For Injection Intramuscular 15,000UNITS Multi-Dose Vial 1985/02/15 Ferring Pharmaceuticals Inc. Disc Licensed N/A N/A
Novarel 017016 009 351(a) chorionic gonadotropin For Injection Intramuscular 2,000UNITS Multi-Dose Vial 1984/12/27 Ferring Pharmaceuticals Inc. Disc Licensed N/A N/A
Chymodiactin 018663 002 351(a) chymopapain For Injection Intrathecal 4,000UNITS Single-Dose Vial 1984/08/21 DisCure Medical, LLC Disc Licensed N/A N/A
Panhematin 101246 001 351(a) Hemin for Injection For Injection Intravenous 350MG Single-Dose Vial 1983/07/20 Recordati Rare Diseases, Inc. Rx Licensed N/A
Microlite 018263 001 351(a) radiolabeled albumin technetium Tc-99m albumin colloid kit Single-Dose Vial 1983/03/25 Pharmalucence Inc Disc Voluntarily Revoked N/A N/A
当前数据更新日期：2025年12月09日，更多信息请点击此处查询美国FDA药品数据库

数据库说明：

©2006-2025 DrugFuture->U.S. FDA Purple Book