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
103060 001 351(a) Insects (Whole Body), Mite Dermatophagoides farinae Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103060 002 351(a) Insects (Whole Body), Mite Dermatophagoides farinae Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103061 001 351(a) Animal Allergens, Standardized Cat Pelt Injection Percutaneous 10,000BAU/ML Dropper Vial 1950/09/29 ALK-Abello, Inc. Rx Voluntarily Revoked N/A
103061 002 351(a) Animal Allergens, Standardized Cat Pelt Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Voluntarily Revoked N/A
103752 001 351(a) Insects (Whole Body), Mite Dermatophagoides pteronyssinus Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103752 002 351(a) Insects (Whole Body), Mite Dermatophagoides pteronyssinus Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
Histatrol 103754 001 351(a) Positive Skin Test Control-Histamine Injection Intradermal 0.1MG/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
Histatrol 103754 002 351(a) Positive Skin Test Control-Histamine Injection Percutaneous 1MG/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
Baygam, Gamastan S/D 101134 001 351(a) Immune Globulin (Human) Injection Intramuscular 0.165 Single-Dose Vial 1944/01/11 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 001 351(a) Albumin (Human) For Injection Intravenous 2.5G/50ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 002 351(a) Albumin (Human) For Injection Intravenous 25G/100ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 003 351(a) Albumin (Human) For Injection Intravenous 20G/100ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 004 351(a) Albumin (Human) For Injection Intravenous 10G/50ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 005 351(a) Albumin (Human) For Injection Intravenous 12.5G/50ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 006 351(a) Albumin (Human) For Injection Intravenous 5G/20ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 007 351(a) Albumin (Human) For Injection Intravenous 25G/500ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 101138 008 351(a) Albumin (Human) For Injection Intravenous 12.5G/250ML Single-Dose Vial 1942/10/21 Grifols Therapeutics LLC Rx Licensed N/A
101062 001 351(a) Antivenin (Latrodectus mactans) For Injection Intravenous NLT6000U Single-Dose Vial 1936/02/13 Merck Sharp & Dohme LLC Rx Licensed N/A
101062 002 351(a) Antivenin (Latrodectus mactans) For Injection Intramuscular NLT6000U Single-Dose Vial 1936/02/13 Merck Sharp & Dohme LLC Rx Licensed N/A
101377 001 351(a) Insects (Whole Body), Mite Dermatophagoides farinae Injection Subcutaneous 10,000AU/ML Multi-Dose Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked N/A
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