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
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	Voluntarily 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
Aduhelm	761178	001	351(a)	aducanumab-avwa	Injection	Intravenous	170MG/1.7ML (100MG/ML)	Single-Dose Vial	2021/06/07	Biogen Inc.	Rx	Licensed	N/A	N/A
Aduhelm	761178	002	351(a)	aducanumab-avwa	Injection	Intravenous	300MG/3ML (100MG/ML)	Single-Dose Vial	2021/06/07	Biogen Inc.	Rx	Licensed	N/A	N/A
Ryplazim	125659	001	351(a)	plasminogen, human-tvmh	For Injection	Intravenous	68.8MG	Single-Dose Vial	2021/06/04	Kedrion Biopharma Inc.	Rx	Licensed		N/A
Cosentyx	125504	004	351(a)	secukinumab	Injection	Subcutaneous	75MG/0.5ML	Pre-Filled Syringe	2021/05/28	Novartis Pharmaceuticals Corporation	Rx	Licensed	N/A	N/A
Rybrevant	761210	001	351(a)	amivantamab-vmjw	Injection	Intravenous	350MG/7ML (50MG/ML)	Single-Dose Vial	2021/05/21	Janssen Biotech, Inc.	Rx	Licensed	N/A	N/A
Pancreaze	022523	006	351(a)	pancrelipase	Capsule, Delayed Release	Oral	37,000USP UNITS; 97,300USP UNITS; 149,900USP UNITS		2021/04/26	VIVUS LLC	Rx	Licensed	N/A	N/A
Skyrizi	761105	002	351(a)	risankizumab-rzaa	Injection	Subcutaneous	150MG/ML	Pre-Filled Syringe	2021/04/26	AbbVie Inc.	Rx	Licensed	N/A	N/A
Skyrizi	761105	003	351(a)	risankizumab-rzaa	Injection	Subcutaneous	150MG/ML	Autoinjector	2021/04/26	AbbVie Inc.	Rx	Licensed	N/A	N/A
Zynlonta	761196	001	351(a)	loncastuximab tesirine-lpyl	For Injection	Intravenous	10MG	Single-Dose Vial	2021/04/23	ADC Therapeutics SA	Rx	Licensed	N/A	N/A
Jemperli	761174	001	351(a)	dostarlimab-gxly	Injection	Intravenous	500MG/10ML (50MG/ML)	Single-Dose Vial	2021/04/22	GlaxoSmithKline LLC	Rx	Licensed	N/A	N/A
Abecma	125736	001	351(a)	idecabtagene vicleucel	Suspension	Intravenous	300 to 460 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS	Bag	2021/03/03	Celgene Corporation, a Bristol-Myers Squibb Company	Rx	Licensed	N/A	N/A
Evkeeza	761181	001	351(a)	evinacumab-dgnb	Injection	Intravenous	345MG/2.3ML (150MG/ML)	Single-Dose Vial	2021/02/11	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A	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	-