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
Skytrofa 761177 1 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 3MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 2 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 3.6MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 3 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 4.3MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 4 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 5.2MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 5 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 6.3MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 6 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 7.6MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 7 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 9.1MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 8 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 11MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Skytrofa 761177 9 351(a) lonapegsomatropin-tcgd For Injection Subcutaneous 13.3MG Single-Dose Cartridge 2021/08/25 Ascendis Pharma Endocrinology Division A/S Rx Licensed N/A N/A
Comirnaty 125742 1 351(a) COVID-19 Vaccine, mRNA For Injection Intramuscular 30UG Multi-Dose Vial 2021/08/23 BioNTech Manufacturing GmbH Rx Licensed N/A N/A
Ticovac 125740 1 351(a) Tick-Borne Encephalitis Vaccine Injection Intramuscular 2.4UG/0.5ML Pre-Filled Syringe 2021/08/13 Pfizer Ireland Pharmaceuticals Rx Licensed N/A N/A
Ticovac 125740 2 351(a) Tick-Borne Encephalitis Vaccine Injection Intramuscular 1.2UG/0.25ML Pre-Filled Syringe 2021/08/13 Pfizer Ireland Pharmaceuticals Rx Licensed N/A N/A
Nexviazyme 761194 1 351(a) avalglucosidase alfa-ngpt For Injection Intravenous 100MG Single-Dose Vial 2021/08/06 Genzyme Corporation Rx Licensed N/A N/A
Saphnelo 761123 1 351(a) anifrolumab-fnia Injection Intravenous 300MG/2ML (150MG/ML) Single-Dose Vial 2021/07/30 AstraZeneca AB Rx Licensed N/A N/A
Semglee 761201 1 351(k) Interchangeable insulin glargine-yfgn Injection Subcutaneous 1,000UNITS/10ML (100UNITS/ML) Multi-Dose Vial 2021/07/28 Mylan Pharmaceuticals Inc. Rx Licensed insulin glargine Lantus
Semglee 761201 2 351(k) Interchangeable insulin glargine-yfgn Injection Subcutaneous 300UNITS/3ML (100UNITS/ML) Autoinjector 2021/07/28 Mylan Pharmaceuticals Inc. Rx Licensed insulin glargine Lantus
Shingrix 125614 2 351(a) Zoster Vaccine Recombinant, Adjuvanted For Injection Intramuscular 50UG Vial 2021/07/23 GlaxoSmithKline Biologicals Rx Licensed N/A N/A
Vaxneuvance 125741 1 351(a) Pneumococcal 15-valent Conjugate Vaccine Injection Intramuscular 0.5ML Pre-Filled Syringe 2021/07/16 Merck Sharp & Dohme Corp. Rx Licensed N/A N/A
Rylaze 761179 1 351(a) asparaginase erwinia chrysanthemi (recombinant)-rywn Injection Intramuscular 10MG/0.5ML Single-Dose Vial 2021/06/30 Jazz Pharmaceuticals Ireland Limited Rx Licensed N/A N/A
StrataGraft 125730 1 351(a) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat Cell Sheets Topical 100CM SQUARED Pouch 2021/06/15 Stratatech Corporation Rx Licensed N/A N/A
当前数据更新日期:2021年10月16日,更多信息请点击此处查询美国FDA药品数据库

数据库说明:

©2006-2021 DrugFuture->U.S. FDA Purple Book