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
Susvimo 761197 1 351(a) ranibizumab Injection Intravitreal 100MG/ML Single-Dose Vial 2021/10/22 Genentech, Inc. Rx Licensed N/A N/A
Dupixent 761055 6 351(a) dupilumab Injection Subcutaneous 100MG/0.67ML Pre-Filled Syringe 2021/10/20 Regeneron Pharmaceuticals, Inc. Rx Licensed N/A N/A
Rethymic 125685 1 351(a) Allogeneic processed Thymus Tissue For Suspension Implantation SEMI-QUANTITATIVE Dish 2021/10/08 Enzyvant Therapeutics GmbH Rx Licensed N/A N/A
Sogroya 761156 2 351(a) somapacitan-beco Injection Subcutaneous 5MG/1.5ML (3.3MG/ML) Autoinjector 2021/10/01 Novo Nordisk Inc. Rx Licensed N/A N/A
Tivdak 761208 1 351(a) tisotumab vedotin-tftv For Injection Intravenous 40MG Single-Dose Vial 2021/09/20 Seagen Inc. Rx Licensed N/A N/A
Byooviz 761202 1 351(k) Biosimilar ranibizumab-nuna Injection Intravitreal 10MG/ML Single-Dose Vial 2021/09/17 Samsung Bioepis Co., Ltd. Rx Licensed ranibizumab Lucentis
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
当前数据更新日期:2022年01月27日,更多信息请点击此处查询美国FDA药品数据库

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