美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
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
CLONIDINE HYDROCHLORIDE 200673 001 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) No No AP 2011/07/08 FRESENIUS KABI USA RX 详细信息
CLONIDINE HYDROCHLORIDE 200673 002 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 5MG/10ML (0.5MG/ML) No No AP 2011/07/08 FRESENIUS KABI USA RX 详细信息
CLONIDINE HYDROCHLORIDE 200300 001 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) No No AP 2011/01/26 HIKMA FARMACEUTICA RX 详细信息
CLONIDINE HYDROCHLORIDE 200300 002 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 5MG/10ML (0.5MG/ML) No Yes AP 2011/01/26 HIKMA FARMACEUTICA RX 详细信息
CLONIDINE HYDROCHLORIDE 203167 001 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) No No AP 2013/10/29 XGEN PHARMS RX 详细信息
CLONIDINE HYDROCHLORIDE 203167 002 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 5MG/10ML (0.5MG/ML) No No AP 2013/10/29 XGEN PHARMS RX 详细信息
CLONIDINE HYDROCHLORIDE 202601 001 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/10ML (0.1MG/ML) No No AP 2014/02/20 ZYDUS PHARMS RX 详细信息
CLONIDINE HYDROCHLORIDE 202601 002 ANDA CLONIDINE HYDROCHLORIDE INJECTABLE;INJECTION 5MG/10ML (0.5MG/ML) No No AP 2014/02/20 ZYDUS PHARMS RX 详细信息
COACTIN 050565 003 NDA AMDINOCILLIN INJECTABLE;INJECTION 1GM/VIAL No No 1984/12/21 ROCHE DISCN 详细信息
COACTIN 050565 001 NDA AMDINOCILLIN INJECTABLE;INJECTION 250MG/VIAL No No 1984/12/21 ROCHE DISCN 详细信息
COACTIN 050565 002 NDA AMDINOCILLIN INJECTABLE;INJECTION 500MG/VIAL No No 1984/12/21 ROCHE DISCN 详细信息
COBAVITE 083013 001 ANDA CYANOCOBALAMIN INJECTABLE;INJECTION 0.1MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
COBAVITE 083064 001 ANDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
COGENTIN 012015 001 NDA BENZTROPINE MESYLATE INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 EPIC PHARMA LLC DISCN 详细信息
COLISTIMETHATE SODIUM 202359 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No AP 2012/09/28 AVET LIFESCIENCES RX 详细信息
COLISTIMETHATE SODIUM 065364 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No AP 2008/04/17 FRESENIUS KABI USA RX 详细信息
COLISTIMETHATE SODIUM 065177 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No 2004/03/19 NEXUS DISCN 详细信息
COLISTIMETHATE SODIUM 064216 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No 1999/02/26 PHARMOBEDIENT DISCN 详细信息
COLISTIMETHATE SODIUM 201365 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No AP 2014/02/19 SAGENT PHARMS INC RX 详细信息
COLISTIMETHATE SODIUM 205356 001 ANDA COLISTIMETHATE SODIUM INJECTABLE;INJECTION EQ 150MG BASE/VIAL No No AP 2015/05/29 XELLIA PHARMS APS RX 详细信息
当前数据更新日期:2025年12月09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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