美国FDA生物制品紫皮书数据库（U.S. FDA Purple Book: Database of Licensed Biological Products）- 药物在线

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	003	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	004	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	005	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	006	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	007	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	008	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	009	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	001	351(a)	COVID-19 Vaccine, mRNA	For Injection	Intramuscular	30UG	Multi-Dose Vial	2021/08/23	BioNTech Manufacturing GmbH	Disc	Licensed	N/A	N/A
Ticovac	125740	001	351(a)	Tick-Borne Encephalitis Vaccine	Injection	Intramuscular	2.4UG/0.5ML	Pre-Filled Syringe	2021/08/13	Pfizer Ireland Pharmaceuticals	Rx	Licensed
Ticovac	125740	002	351(a)	Tick-Borne Encephalitis Vaccine	Injection	Intramuscular	1.2UG/0.25ML	Pre-Filled Syringe	2021/08/13	Pfizer Ireland Pharmaceuticals	Rx	Licensed
Nexviazyme	761194	001	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	001	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	001	351(k) Interchangeable	insulin glargine-yfgn	Injection	Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2021/07/28	Biocon Biologics Inc.	Rx	Licensed	insulin glargine	Lantus
Semglee	761201	002	351(k) Interchangeable	insulin glargine-yfgn	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2021/07/28	Biocon Biologics Inc.	Rx	Licensed	insulin glargine	Lantus
Shingrix	125614	002	351(a)	Zoster Vaccine Recombinant, Adjuvanted	For Injection	Intramuscular	50UG	Vial	2021/07/23	GlaxoSmithKline Biologicals	Rx	Licensed	N/A
Vaxneuvance	125741	001	351(a)	Pneumococcal 15-valent Conjugate Vaccine	Injection	Intramuscular	2.0UG	Pre-Filled Syringe	2021/07/16	Merck Sharp & Dohme LLC	Rx	Licensed	N/A
Rylaze	761179	001	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	001	351(a)	Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat	Cell Sheets	Topical	100CM SQUARED	Pouch	2021/06/15	Stratatech Corporation	Disc	Revoked	N/A	N/A
Dupixent	761055	005	351(a)	dupilumab	Injection	Subcutaneous	200MG/1.14ML	Autoinjector	2021/06/14	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	N/A
Prevnar 20	125731	001	351(a)	Pneumococcal 20-valent Conjugate Vaccine	Injection	Intramuscular	0.5 ML	Pre-Filled Syringe	2021/06/08	Wyeth Pharmaceuticals LLC	Rx	Licensed		N/A

药品商品名或专利药名Proprietary (Brand) Name
药品通用名或非专利名称Nonproprietary (Proper) Name
药品申请号BLA Number
产品号Product Number
剂型Dosage Form
给药途径Route of Administration
产品形式Product Presentation
药品规格或剂量Strength
药品注册申请人Applicant
参考产品非专利名称Reference Product Proper Name
参考产品专利名称Reference Product Proprietary Name
BLA类型BLA Type
药品的市场状态Marketing Status
许可证号License Number
许可证状态Licensure
产品批准日期Approval Date	-