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
N/A 103397 3 351(a) Animal Allergens, Standardized Cat Hair Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed
N/A 103397 4 351(a) Animal Allergens, Standardized Cat Hair Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed
N/A 103397 5 351(a) Animal Allergens, Standardized Cat Hair Injection Intradermal 5,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed
N/A 103397 6 351(a) Animal Allergens, Standardized Cat Hair Injection Subcutaneous 5,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed
N/A 103397 7 351(a) Animal Allergens, Standardized Cat Hair Injection Percutaneous 5,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed
Baytet, Hypertet 101142 1 351(a) Tetanus Immune Globulin (Human) Injection Intramuscular 250U Pre-Filled Syringe 1957/10/17 Grifols Therapeutics LLC Rx Licensed
Buminate, Flexbumin 101452 1 351(a) Albumin (Human) Injection Intravenous 20G/100ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
Buminate, Flexbumin 101452 2 351(a) Albumin (Human) Injection Intravenous 25G/100ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
Buminate, Flexbumin 101452 3 351(a) Albumin (Human) Injection Intravenous 12.5G/50ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
Buminate, Flexbumin 101452 4 351(a) Albumin (Human) Injection Intravenous 10G/50ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
Buminate, Flexbumin 101452 5 351(a) Albumin (Human) Injection Intravenous 12.5G/250ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed
N/A 101098 1 351(a) Antivenin (Crotalidae) Polyvalent For Injection Intravenous 10ML Vial 1954/02/08 Wyeth Pharmaceuticals LLC Disc Voluntarily Revoked
N/A 103052 1 351(a) Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103052 2 351(a) Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103052 3 351(a) Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis Injection Percutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103052 4 351(a) Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis Injection Subcutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103053 1 351(a) Pollens - Grasses, Fescue, Meadow Festuca elatior Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103053 2 351(a) Pollens - Grasses, Fescue, Meadow Festuca elatior Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103053 3 351(a) Pollens - Grasses, Fescue, Meadow Festuca elatior Injection Percutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
N/A 103053 4 351(a) Pollens - Grasses, Fescue, Meadow Festuca elatior Injection Subcutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed
当前数据更新日期:2024年05月02日,更多信息请点击此处查询美国FDA药品数据库

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