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
Gonal-f RFF RediJect	021684	002	351(a)	follitropin alfa	Injection	Subcutaneous	450IU/0.75ML	Autoinjector	2004/05/25	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Gonal-f RFF RediJect	021684	003	351(a)	follitropin alfa	Injection	Subcutaneous	900IU/1.5ML	Autoinjector	2004/05/25	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Octagam	125062	001	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5% 5.0G	Single-Use Bottle	2004/05/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Octagam	125062	002	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5% 1.0G	Single-Use Bottle	2004/05/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Octagam	125062	003	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5% 10G	Single-Use Bottle	2004/05/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Octagam	125062	004	351(a)	Immune Globulin Intravenous (Human)	Injection	Intravenous	5% 2.5G	Single-Use Bottle	2004/05/21	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Vitrase	021640	001	351(a)	hyaluronidase	Injection	Infiltration, Interstitial, Intramuscular, Intraocular, Peribulbar, Retrobulbar, Soft Tissue, Subcutaneous	6,200UNITS/ML	Single-Dose Vial	2004/05/05	Bausch & Lomb Incorporated	Disc	Licensed	N/A	N/A
Novolog	020986	004	351(a)	insulin aspart	Injection	Subcutaneous	300UNITS/3ML (100UNITS/ML)	Autoinjector	2004/04/23	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Apidra	021629	001	351(a)	insulin glulisine	Injection	Intravenous, Subcutaneous	1,000UNITS/10ML (100UNITS/ML)	Multi-Dose Vial	2004/04/16	Sanofi-Aventis U.S. LLC	Rx	Licensed	N/A	N/A
Gonal-f	020378	005	351(a)	follitropin alfa	For Injection	Subcutaneous	450IU (600IU/ML)	Multi-Dose Vial	2004/03/26	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Gonal-f	020378	003	351(a)	follitropin alfa	For Injection	Subcutaneous	37.5IU	Ampule	2004/03/25	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Gonal-f RFF	021765	001	351(a)	follitropin alfa	For Injection	Subcutaneous	37.5IU	Single-Dose Vial	2004/03/25	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Gonal-f RFF	021765	002	351(a)	follitropin alfa	For Injection	Subcutaneous	75IU	Single-Dose Vial	2004/03/25	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
Gonal-f RFF	021765	003	351(a)	follitropin alfa	For Injection	Subcutaneous	150IU	Single-Dose Vial	2004/03/25	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Follistim AQ Cartridge	021211	001	351(a)	follitropin beta	Injection	Subcutaneous	300IU/0.36ML	Multi-Dose Cartridge	2004/03/23	Organon USA LLC, a subsidiary of Organon & Co.	Rx	Licensed	N/A	N/A
Follistim AQ Cartridge	021211	002	351(a)	follitropin beta	Injection	Subcutaneous	600IU/0.72ML	Multi-Dose Cartridge	2004/03/23	Organon USA LLC, a subsidiary of Organon & Co.	Rx	Licensed	N/A	N/A
Monoclate, Monoclate-P	103953	004	351(a)	Antihemophilic Factor (Human)	For Injection	Intravenous	1500IU	Vial	2004/03/04	CSL Behring LLC	Disc	Voluntarily Revoked		N/A
Avastin	125085	001	351(a)	bevacizumab	Injection	Intravenous	100MG/4ML (25MG/ML)	Single-Dose Vial	2004/02/26	Genentech, Inc.	Rx	Licensed	N/A	N/A
Avastin	125085	002	351(a)	bevacizumab	Injection	Intravenous	400MG/16ML (25MG/ML)	Single-Dose Vial	2004/02/26	Genentech, Inc.	Rx	Licensed	N/A	N/A
Rhophylac	125070	001	351(a)	Rho(D) Immune Globulin Intravenous (Human)	Injection	Intramuscular	1500IU/ML	Pre-Filled Syringe	2004/02/12	CSL Behring AG	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	-