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
101845 005 351(a) Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior Injection Intradermal 100,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed N/A
101845 006 351(a) Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior Injection Subcutaneous 100,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed N/A
103397 001 351(a) Animal Allergens, Standardized Cat Hair Injection Percutaneous 10,000BAU/ML Dropper Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed N/A
103397 002 351(a) Animal Allergens, Standardized Cat Hair Injection Intradermal 10,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed N/A
103397 003 351(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 004 351(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 005 351(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 006 351(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 007 351(a) Animal Allergens, Standardized Cat Hair Injection Percutaneous 5,000BAU/ML Multi-Dose Vial 1958/09/15 Greer Laboratories, Inc. Rx Licensed N/A
Baytet, Hypertet 101142 001 351(a) Tetanus Immune Globulin (Human) Injection Intramuscular 250U Pre-Filled Syringe 1957/10/17 Grifols Therapeutics LLC Rx Licensed N/A
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
当前数据更新日期:2025年12月07日,更多信息请点击此处查询美国FDA药品数据库

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