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
Buminate, Flexbumin 101452 001 351(a) Albumin (Human) Injection Intravenous 20G/100ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
Buminate, Flexbumin 101452 002 351(a) Albumin (Human) Injection Intravenous 25G/100ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
Buminate, Flexbumin 101452 003 351(a) Albumin (Human) Injection Intravenous 12.5G/50ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
Buminate, Flexbumin 101452 004 351(a) Albumin (Human) Injection Intravenous 10G/50ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
Buminate, Flexbumin 101452 005 351(a) Albumin (Human) Injection Intravenous 12.5G/250ML Bottle 1954/03/03 Takeda Pharmaceuticals U.S.A., Inc. Rx Licensed N/A
101098 001 351(a) Antivenin (Crotalidae) Polyvalent For Injection Intravenous 10ML Vial 1954/02/08 Wyeth Pharmaceuticals LLC Disc Voluntarily Revoked N/A
103052 001 351(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 002 351(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 003 351(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 004 351(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 001 351(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 002 351(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 003 351(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 004 351(a) Pollens - Grasses, Fescue, Meadow Festuca elatior Injection Subcutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103054 001 351(a) Pollens - Grasses, Orchard Grass Dactylis glomerata Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103054 002 351(a) Pollens - Grasses, Orchard Grass Dactylis glomerata Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103054 003 351(a) Pollens - Grasses, Orchard Grass Dactylis glomerata Injection Percutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103054 004 351(a) Pollens - Grasses, Orchard Grass Dactylis glomerata Injection Subcutaneous 100,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103055 001 351(a) Pollens - Grasses, Redtop Agrostis alba Injection Percutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
103055 002 351(a) Pollens - Grasses, Redtop Agrostis alba Injection Subcutaneous 10,000BAU/ML Multi-Dose Vial 1950/09/29 ALK-Abello, Inc. Rx Licensed N/A
当前数据更新日期:2026年02月09日,更多信息请点击此处查询美国FDA药品数据库

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