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
Pulmozyme	103532	001	351(a)	dornase alfa	Solution	Inhalation	2.5MG/2.5ML (1MG/ML)	Ampule	1993/12/30	Genentech, Inc.	Rx	Licensed	N/A	N/A
Trasylol	020304	001	351(a)	aprotinin	Injection	Intravenous	1,000,000KIU/100ML (10,000KIU/ML)	Single-Dose Vial	1993/12/29	Bayer HealthCare Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Trasylol	020304	002	351(a)	aprotinin	Injection	Intravenous	2,000,000KIU/200ML (10,000KIU/ML)	Single-Dose Vial	1993/12/29	Bayer HealthCare Pharmaceuticals Inc.	Disc	Licensed	N/A	N/A
Nutropin	020168	001	351(a)	somatropin	For Injection	Subcutaneous	5MG	Multi-Dose Vial	1993/11/17	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Nutropin	020168	002	351(a)	somatropin	For Injection	Subcutaneous	10MG	Multi-Dose Vial	1993/11/17	Genentech, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Betaseron	103471	001	351(a)	interferon beta-1b	For Injection	Subcutaneous	0.3MG	Single-Dose Vial	1993/07/23	Bayer HealthCare Pharmaceuticals Inc.	Rx	Licensed	N/A	N/A
Bioclate (Armour), Recombinate	103375	001	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	1000IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	002	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	500IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Bioclate (Armour), Recombinate	103375	003	351(a)	Antihemophilic Factor (Recombinant)	For Injection	Intravenous	250IU	Single-Dose Vial	1992/12/10	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Orthoclone OKT3	103463	001	351(a)	muromonab-CD3	Injection	Intravenous	1MG/ML	Ampule	1992/09/14	Centocor Ortho Biotech Products, L.P.	Disc	Voluntarily Revoked	N/A	N/A
Proleukin	103293	001	351(a)	aldesleukin	For Injection	Intravenous	22MILLION INTERNATIONAL UNITS (1.3MG)	Single-Dose Vial	1992/05/05	Iovance Biotherapeutics Manufacturing LLC	Rx	Licensed	N/A	N/A
	103317	001	351(a)	Positive Skin Test Control-Histamine	Injection	Percutaneous	1.8MG/ML	Vial	1992/02/14	Nielsen Bioscience, Inc	Disc	Licensed		N/A
Thrombate Iii	103196	001	351(a)	Antithrombin III (Human)	For Injection	Intravenous	500IU	Single-Dose Vial	1991/12/30	Grifols Therapeutics LLC	Rx	Licensed		N/A
Botox Cosmetic	103000	001	351(a)	onabotulinumtoxinA	For Injection	Intramuscular	50UNITS	Single-Dose Vial	1991/12/09	AbbVie Inc.	Rx	Licensed	N/A	N/A
Botox Cosmetic	103000	002	351(a)	onabotulinumtoxinA	For Injection	Intramuscular	100UNITS	Single-Dose Vial	1991/12/09	AbbVie Inc.	Rx	Licensed	N/A	N/A
Botox	103000	003	351(a)	onabotulinumtoxinA	For Injection	Injection, Intramuscular, Intradermal, Intradetrusor	50UNITS	Single-Dose Vial	1991/12/09	AbbVie Inc.	Disc	Licensed	N/A	N/A
Botox	103000	004	351(a)	onabotulinumtoxinA	For Injection	Injection, Intramuscular, Intradermal, Intradetrusor	100UNITS	Single-Dose Vial	1991/12/09	AbbVie Inc.	Rx	Licensed	N/A	N/A
Botox	103000	005	351(a)	onabotulinumtoxinA	For Injection	Injection, Intramuscular, Intradermal, Intradetrusor	200UNITS	Single-Dose Vial	1991/12/09	AbbVie Inc.	Rx	Licensed	N/A	N/A
Pharmalgen	103969	001	351(a)	Venoms, Honey Bee Venom	For Injection	Subcutaneous	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		N/A
Pharmalgen	103969	002	351(a)	Venoms, Honey Bee Venom	For Injection	Intradermal	100UG/ML	Multi-Dose Vial	1991/10/08	ALK - Abello A/S	Disc	Voluntarily Revoked		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	-