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
Pegintron	103949	005	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	50MCG/0.5ML	Autoinjector	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	006	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	80MCG/0.5ML	Autoinjector	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	007	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	80MCG/0.5ML	Single-Dose Vial	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	008	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	120MCG/0.5ML	Autoinjector	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	009	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	120MCG/0.5ML	Single-Dose Vial	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	010	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	150MCG/0.5ML	Autoinjector	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Pegintron	103949	011	351(a)	peginterferon alfa-2b	Injection	Subcutaneous	150MCG/0.5ML	Single-Dose Vial	2001/01/19	Merck Sharp & Dohme LLC	Disc	Voluntarily Revoked	N/A	N/A
Myobloc	103846	001	351(a)	rimabotulinumtoxinB	Injection	Intramuscular, Intraglandular	2,500UNITS/0.5ML	Single-Dose Vial	2000/12/08	Solstice NeuroSciences, LLC	Rx	Licensed	N/A	N/A
Myobloc	103846	002	351(a)	rimabotulinumtoxinB	Injection	Intramuscular, Intraglandular	5,000UNITS/ML	Single-Dose Vial	2000/12/08	Solstice NeuroSciences, LLC	Rx	Licensed	N/A	N/A
Myobloc	103846	003	351(a)	rimabotulinumtoxinB	Injection	Intramuscular, Intraglandular	10,000UNITS/2ML (5,000UNITS/ML)	Single-Dose Vial	2000/12/08	Solstice NeuroSciences, LLC	Rx	Licensed	N/A	N/A
Novoseven, Novoseven Rt	103665	002	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	1.2MG	Vial	2000/11/15	Novo Nordisk Inc.	Disc	Licensed		N/A
Novoseven, Novoseven Rt	103665	003	351(a)	Coagulation Factor VIIa (Recombinant)	For Injection	Intravenous	4.8MG	Vial	2000/11/15	Novo Nordisk Inc.	Disc	Licensed		N/A
Crofab	103788	001	351(a)	Crotalidae Polyvalent Immune Fab (Ovine)	For Injection	Intravenous	1G	Single-Dose Vial	2000/10/02	BTG International Inc.	Rx	Licensed		N/A
Ovidrel	021149	001	351(a)	choriogonadotropin alfa	Injection	Subcutaneous	250MCG	Single-Dose Vial	2000/09/20	EMD Serono, Inc.	Disc	Licensed	N/A	N/A
Saizen	019764	003	351(a)	somatropin	For Injection	Subcutaneous	8.8MG	Single-Dose Vial	2000/08/29	EMD Serono, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Autoplex, Feiba Nf, Feiba Vh	101447	003	351(a)	Anti-Inhibitor Coagulant Complex	For Injection	Intravenous	1000U	Single-Dose Vial	2000/07/31	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Autoplex, Feiba Nf, Feiba Vh	101447	004	351(a)	Anti-Inhibitor Coagulant Complex	For Injection	Intravenous	500U	Bottle	2000/07/31	Takeda Pharmaceuticals U.S.A., Inc.	Rx	Licensed		N/A
Carimune, Carimune Nf, Panglobulin, Sandoglobulin	102367	001	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	6G	Single-Dose Vial	2000/07/27	CSL Behring AG	Disc	Voluntarily Revoked		N/A
Carimune, Carimune Nf, Panglobulin, Sandoglobulin	102367	002	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	12G	Single-Dose Vial	2000/07/27	CSL Behring AG	Disc	Voluntarily Revoked		N/A
Carimune, Carimune Nf, Panglobulin, Sandoglobulin	102367	003	351(a)	Immune Globulin Intravenous (Human)	For Injection	Intravenous	3G	Single-Dose Vial	2000/07/27	CSL Behring AG	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	-