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
Norditropin	021148	006	351(a)	somatropin	Injection	Subcutaneous	15MG/1.5ML	Autoinjector	2004/10/01	Novo Nordisk Inc.	Disc	Licensed	N/A	N/A
Enbrel	103795	003	351(a)	etanercept	Injection	Subcutaneous	50MG/ML	Pre-Filled Syringe	2004/09/27	Immunex Corporation	Rx	Licensed	N/A	N/A
Synagis	103770	003	351(a)	palivizumab	Injection	Intramuscular	50MG/0.5ML	Single-Dose Vial	2004/07/23	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
Synagis	103770	004	351(a)	palivizumab	Injection	Intramuscular	100MG/1ML	Single-Dose Vial	2004/07/23	Swedish Orphan Biovitrum AB (publ)	Rx	Licensed	N/A	N/A
NeutroSpec	103928	001	351(a)	technetium 99m tc fanolesomab	Injection	Intravenous	0.25MG	Single-Dose Vial	2004/07/02	Palatin Technologies, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Jeanatope	017836	003	351(a)	iodinated I-125 albumin	Injection	Intravenous	100uCi/10ML (10uCi/ML)	Multi-Dose Vial	2004/06/08	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Pegasys Copegus Combination Pack	125083	001	351(a)	peginterferon alfa-2a and ribavirin			180MCG/0.5ML & 800MG		2004/06/04	Hoffmann-La Roche Inc.	Disc	Voluntarily Revoked	N/A	N/A
Pegasys Copegus Combination Pack	125083	002	351(a)	peginterferon alfa-2a and ribavirin			180MCG/0.5ML &1000MG		2004/06/04	Hoffmann-La Roche Inc.	Disc	Voluntarily Revoked	N/A	N/A
Pegasys Copegus Combination Pack	125083	003	351(a)	peginterferon alfa-2a and ribavirin			180MCG/0.5ML & 1200MG		2004/06/04	Hoffmann-La Roche Inc.	Disc	Voluntarily Revoked	N/A	N/A
Gonal-f RFF RediJect	021684	001	351(a)	follitropin alfa	Injection	Subcutaneous	300IU/0.5ML	Autoinjector	2004/05/25	EMD Serono, Inc.	Rx	Licensed	N/A	N/A
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

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	-