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
Veopoz	761339	1	351(a)	pozelimab-bbfg	Injection	Intravenous, Subcutaneous	400MG/2ML (200MG/ML)	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A
Eylea HD	761355	1	351(a)	aflibercept	Injection	Intravitreal	8MG/0.07ML	Single-Dose Vial	2023/08/18	Regeneron Pharmaceuticals, Inc.	Rx	Licensed	N/A
Amjevita	761024	5	351(k) Biosimilar	adalimumab-atto	Injection	Subcutaneous	20MG/0.2ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	6	351(k) Biosimilar	adalimumab-atto	Injection	Subcutaneous	40MG/0.4ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	7	351(k) Biosimilar	adalimumab-atto	Injection	Subcutaneous	80MG/0.8ML	Pre-Filled Syringe	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	8	351(k) Biosimilar	adalimumab-atto	Injection	Subcutaneous	40MG/0.4ML	Autoinjector	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Amjevita	761024	9	351(k) Biosimilar	adalimumab-atto	Injection	Subcutaneous	80MG/0.8ML	Autoinjector	2023/08/14	Amgen Inc.	Rx	Licensed	adalimumab	Humira
Elrexfio	761345	1	351(a)	elranatamab-bcmm	Injection	Subcutaneous	76MG/1.9ML (40MG/ML)	Single-Dose Vial	2023/08/14	Pfizer Inc.	Rx	Licensed	N/A
Elrexfio	761345	2	351(a)	elranatamab-bcmm	Injection	Subcutaneous	44MG/1.1ML (40MG/ML)	Single-Dose Vial	2023/08/14	Pfizer Inc.	Rx	Licensed	N/A
Talvey	761342	1	351(a)	talquetamab-tgvs	Injection	Subcutaneous	3MG/1.5ML (2MG/ML)	Single-Dose Vial	2023/08/09	Janssen Biotech, Inc.	Rx	Licensed	N/A
Talvey	761342	2	351(a)	talquetamab-tgvs	Injection	Subcutaneous	40MG/ML	Single-Dose Vial	2023/08/09	Janssen Biotech, Inc.	Rx	Licensed	N/A
Balfaxar	125776	1	351(a)	Prothrombin complex concentrate, human-lans	For Injection	Intravenous	500IU	Single-Dose Vial	2023/07/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed
CYFENDUS	125761	1	351(a)	Anthrax Vaccine Adsorbed, Adjuvanted	Injection	Intramuscular	100UG/ML	Multi-Dose Vial	2023/07/20	Emergent Product Development Gaithersburg, Inc.	Rx	Licensed	N/A
Beyfortus	761328	1	351(a)	nirsevimab-alip	Injection	Intramuscular	50MG/0.5ML	Pre-Filled Syringe	2023/07/17	AstraZeneca AB	Rx	Licensed	N/A
Roctavian	125720	1	351(a)	valoctocogene roxaparvovec-rvox	Injection	Intravenous	16X 10E13GENOMES PER ML	Single-Dose Vial	2023/06/29	Biomarin Pharmaceutical Inc.	Rx	Licensed
Lantidra	125734	1	351(a)	donislecel-jujn	Suspension	Intravenous	1X10E6EQUIVALENT ISLET NUMBER (EIN)	Bag	2023/06/28	CellTrans Inc.	Rx	Licensed
Ngenla	761184	1	351(a)	somatrogon-ghla	Injection	Subcutaneous	24MG/1.2ML (20MG/ML)	Autoinjector	2023/06/27	Pfizer Ireland Pharmaceuticals	Rx	Licensed	N/A
Ngenla	761184	2	351(a)	somatrogon-ghla	Injection	Subcutaneous	60MG/1.2ML (50MG/ML)	Autoinjector	2023/06/27	Pfizer Ireland Pharmaceuticals	Rx	Licensed	N/A
Rystiggo	761286	1	351(a)	rozanolixizumab-noli	Injection	Subcutaneous	280MG/2ML (140MG/ML)	Single-Dose Vial	2023/06/26	UCB, Inc.	Rx	Licensed	N/A
ELEVIDYS	125781	1	351(a)	delandistrogene moxeparvovec-rokl	Suspension	Intravenous	1.33 ×10E14 vector genomes (vg)/kg/bodyweight(bw)	Single-Dose Vial	2023/06/22	Sarepta Therapeutics, Inc.	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	-