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 2182 条，共 110 页，当前第 99 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
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
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
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
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
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
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
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
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
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
101062 001 351(a) Antivenin (Latrodectus mactans) For Injection Intravenous NLT6000U Single-Dose Vial 1936/02/13 Merck Sharp & Dohme LLC Rx Licensed
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 101377 002 351(a) Insects (Whole Body), Mite Dermatophagoides farinae Injection Percutaneous 10,000AU/ML Dropper Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 101378 001 351(a) Insects (Whole Body), Mite Dermatophagoides pteronyssinus Injection Percutaneous 10,000AU/ML Dropper Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 101378 002 351(a) Insects (Whole Body), Mite Dermatophagoides pteronyssinus Injection Subcutaneous 10,000AU/ML Multi-Dose Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 103324 001 351(a) Animal Allergens, Standardized Cat Hair Injection Percutaneous 10,000BAU/ML Dropper Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 103324 002 351(a) Animal Allergens, Standardized Cat Hair Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1930/07/11 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 101379 001 351(a) Pollens - Grasses, Bermuda Grass Cynodon dactylon Injection Percutaneous 10,000BAU/ML Dropper Vial 1930/06/14 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 101379 002 351(a) Pollens - Grasses, Bermuda Grass Cynodon dactylon Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1930/06/14 Allergy Laboratories, Inc. Disc Voluntarily Revoked
N/A 101380 001 351(a) Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis Injection Percutaneous 10,000BAU/ML Dropper Vial 1930/06/14 Allergy Laboratories, Inc. Disc Voluntarily Revoked
当前数据更新日期：2026年06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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