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
CAPVAXIVE	125814	001	351(a)	Pneumococcal 21-valent Conjugate Vaccine	Injection	Intramuscular	84UG/.5ML	Pre-Filled Syringe	2024/06/17	Merck Sharp & Dohme LLC	Rx	Licensed
YIMMUGO	125810	001	351(a)	immune globulin intravenous, human-dira	For Injection	Intravenous	5G/50ML	Single-Dose Vial	2024/06/13	YIMMUGO	Rx	Licensed
YIMMUGO	125810	002	351(a)	immune globulin intravenous, human-dira	For Injection	Intravenous	10G/100ML	Single-Dose Vial	2024/06/13	YIMMUGO	Rx	Licensed
YIMMUGO	125810	003	351(a)	immune globulin intravenous, human-dira	For Injection	Intravenous	20G/200ML	Single-Dose Vial	2024/06/13	YIMMUGO	Rx	Licensed
Adbry	761180	002	351(a)	tralokinumab-ldrm	Injection	Subcutaneous	300MG/2ML	Autoinjector	2024/06/12	LEO Pharma A/S	Rx	Licensed
mresvia	125796	001	351(a)	Respiratory Syncytial Virus Vaccine, mRNA (mRNA-1345)	For Injection	Intramuscular	50UG/.5ML	Pre-Filled Syringe	2024/05/31	ModernaTX, Inc.	Rx	Licensed
Bkemv	761333	001	351(k) Interchangeable	eculizumab-aeeb	Injection	Intravenous	300MG/30ML (10MG/ML)	Single-Dose Vial	2024/05/28	Amgen Inc.	Rx	Licensed	eculizumab	Soliris
Yesafili	761274	001	351(k) Interchangeable	aflibercept-jbvf	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/05/20	Biocon Biologics Inc.	Rx	Licensed	aflibercept	Eylea
Opuviz	761350	001	351(k) Interchangeable	aflibercept-yszy	Injection	Intravitreal	2MG/0.05ML	Single-Dose Vial	2024/05/20	Samsung Bioepis Co., Ltd.	Rx	Licensed	aflibercept	Eylea
Imdelltra	761344	001	351(a)	tarlatamab-dlle	Injection	Intravenous	1MG	Single-Dose Vial	2024/05/16	Amgen Inc.	Rx	Licensed
Imdelltra	761344	002	351(a)	tarlatamab-dlle	Injection	Intravenous	10MG	Single-Dose Vial	2024/05/16	Amgen Inc.	Rx	Licensed
Eticovo	761066	003	351(k) Biosimilar	etanercept-ykro	Injection	Subcutaneous	50MG/ML	Autoinjector	2024/05/03	Samsung Bioepis Co., Ltd.	Disc	Licensed	etanercept	Enbrel
Cyltezo	761058	005	351(k) Biosimilar	adalimumab-adbm	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2024/04/30	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
Cyltezo	761058	006	351(k) Biosimilar	adalimumab-adbm	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2024/04/30	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
BEQVEZ	125786	001	351(a)	fidanacogene elaparvovec-dzkt	Suspension	Intravenous	1x E13 VG/ML	Single-Dose Vial	2024/04/25	Pfizer Inc.	Rx	Licensed
Hercessi	761346	001	351(k) Biosimilar	trastuzumab-strf	Injection	Intravenous	150MG	Single-Dose Vial	2024/04/25	Accord BioPharma Inc.	Rx	Licensed	trastuzumab	Herceptin
Anktiva	761336	001	351(a)	nogapendekin alfa inbakicept-pmln	Solution	Intravesical	400MCG/0.4ML	Single-Dose Vial	2024/04/22	Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.	Rx	Licensed
Selarsdi	761343	001	351(k) Biosimilar	ustekinumab-aekn	Injection	Subcutaneous	45MG/0.5ML	Pre-Filled Syringe	2024/04/16	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Selarsdi	761343	002	351(k) Biosimilar	ustekinumab-aekn	Injection	Subcutaneous	90MG/ML	Pre-Filled Syringe	2024/04/16	Alvotech USA Inc.	Rx	Licensed	ustekinumab	Stelara
Fasenra	761070	003	351(a)	benralizumab	Injection	Subcutaneous	10MG/0.5ML	Pre-Filled Syringe	2024/04/05	AstraZeneca AB	Rx	Licensed

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	-