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
Proleukin 103293 001 351(a) aldesleukin For Injection Intravenous 22MILLION INTERNATIONAL UNITS (1.3MG) Single-Dose Vial 1992/05/05 Iovance Biotherapeutics Manufacturing LLC Rx Licensed N/A N/A
103317 001 351(a) Positive Skin Test Control-Histamine Injection Percutaneous 1.8MG/ML Vial 1992/02/14 Nielsen Bioscience, Inc Disc Licensed N/A
Thrombate Iii 103196 001 351(a) Antithrombin III (Human) For Injection Intravenous 500IU Single-Dose Vial 1991/12/30 Grifols Therapeutics LLC Rx Licensed N/A
Botox Cosmetic 103000 001 351(a) onabotulinumtoxinA For Injection Intramuscular 50UNITS Single-Dose Vial 1991/12/09 AbbVie Inc. Rx Licensed N/A N/A
Botox Cosmetic 103000 002 351(a) onabotulinumtoxinA For Injection Intramuscular 100UNITS Single-Dose Vial 1991/12/09 AbbVie Inc. Rx Licensed N/A N/A
Botox 103000 003 351(a) onabotulinumtoxinA For Injection Injection, Intramuscular, Intradermal, Intradetrusor 50UNITS Single-Dose Vial 1991/12/09 AbbVie Inc. Disc Licensed N/A N/A
Botox 103000 004 351(a) onabotulinumtoxinA For Injection Injection, Intramuscular, Intradermal, Intradetrusor 100UNITS Single-Dose Vial 1991/12/09 AbbVie Inc. Rx Licensed N/A N/A
Botox 103000 005 351(a) onabotulinumtoxinA For Injection Injection, Intramuscular, Intradermal, Intradetrusor 200UNITS Single-Dose Vial 1991/12/09 AbbVie Inc. Rx Licensed N/A N/A
Pharmalgen 103969 001 351(a) Venoms, Honey Bee Venom For Injection Subcutaneous 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103969 002 351(a) Venoms, Honey Bee Venom For Injection Intradermal 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103970 001 351(a) Venoms, Mixed Vespid Venom Protein For Injection Subcutaneous 300UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103970 002 351(a) Venoms, Mixed Vespid Venom Protein For Injection Intradermal 300UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103971 001 351(a) Venoms, Wasp Venom Protein For Injection Subcutaneous 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103971 002 351(a) Venoms, Wasp Venom Protein For Injection Intradermal 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103972 001 351(a) Venoms, White Faced Hornet Venom Protein For Injection Subcutaneous 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103972 002 351(a) Venoms, White Faced Hornet Venom Protein For Injection Intradermal 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103973 001 351(a) Venoms, Yellow Hornet Venom Protein For Injection Subcutaneous 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103973 002 351(a) Venoms, Yellow Hornet Venom Protein For Injection Intradermal 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103974 001 351(a) Venoms, Yellow Jacket Venom Protein For Injection Subcutaneous 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
Pharmalgen 103974 002 351(a) Venoms, Yellow Jacket Venom Protein For Injection Intradermal 100UG/ML Multi-Dose Vial 1991/10/08 ALK - Abello A/S Disc Voluntarily Revoked N/A
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