美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 45509 条，共 2276 页，当前第 1 页
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商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
BUTORPHANOL TARTRATE 078247 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 2009/04/29 HIKMA FARMACEUTICA DISCN 详细信息
BUTORPHANOL TARTRATE 078400 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No AP 2009/05/01 HIKMA FARMACEUTICA RX 详细信息
BUTORPHANOL TARTRATE 075342 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No 1999/11/04 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE 075559 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No 2000/03/20 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE 075342 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 1999/11/04 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE 075559 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 2000/03/20 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075695 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No 2001/10/23 BAXTER HLTHCARE CORP DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075695 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 2001/10/23 BAXTER HLTHCARE CORP DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075045 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No AP 1998/08/12 HIKMA RX 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075045 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No AP 1998/08/12 HIKMA RX 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 074620 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No 1997/01/22 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 074626 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No Yes AP 1997/01/23 HOSPIRA RX 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075170 001 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No No 1998/09/28 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 074620 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 1997/01/22 HOSPIRA DISCN 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 074626 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No Yes AP 1997/01/23 HOSPIRA RX 详细信息
BUTORPHANOL TARTRATE PRESERVATIVE FREE 075170 002 ANDA BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No 1998/09/28 HOSPIRA DISCN 详细信息
CALAN 019038 001 NDA VERAPAMIL HYDROCHLORIDE INJECTABLE;INJECTION 2.5MG/ML No No 1984/03/30 GD SEARLE LLC DISCN 详细信息
CALCIJEX 018874 001 NDA CALCITRIOL INJECTABLE;INJECTION 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1986/09/25 ABBVIE DISCN 详细信息
CALCIJEX 018874 002 NDA CALCITRIOL INJECTABLE;INJECTION 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1986/09/25 ABBVIE DISCN 详细信息
CALCIMAR 017769 001 NDA CALCITONIN SALMON INJECTABLE;INJECTION 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
当前数据更新日期：2024年10月03日，更多信息请点击此处查询美国FDA药品数据库
数据库说明：本数据与美国FDA官方药品橙皮书数据库同步，在官方数据基础上，提供更全面的检索方式和更简洁高效、完整的数据展现，并且可以回溯专利及市场独占权（市场排他数据）历史信息。
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