药品名称REGLAN
申请号017862产品号001
活性成分METOCLOPRAMIDE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 5MG BASE/ML
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
017862063APLetter2010/11/22下载
017862063APLabel2010/11/26下载
017862063APMedication Guide2010/11/26下载
017862061APLetter2009/07/06下载
017862061APLabel2009/07/09下载
017862051APLetter2004/04/29下载
017862050APLetter2004/04/29下载
017862048APLetter2002/11/25下载
017862042APReview2001/06/18下载
017862000APMedication Guide2009/11/20下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
017862063AP2010/11/18Labeling Revision
017862061AP2009/06/30Labeling Revision
017862051AP2004/04/19Labeling Revision
017862050AP2004/04/19Labeling Revision
017862048AP2001/11/07Labeling Revision
017862047AP2001/01/29Control Supplement
017862046AP2001/01/22Control Supplement
017862045AP2001/01/22Control Supplement
017862043AP1999/08/27Manufacturing Change or Addition
017862042AP1999/03/09Labeling Revision
017862041AP1998/01/30Manufacturing Change or Addition
017862040AP2000/06/01Labeling Revision
017862039AP1996/06/24Labeling Revision
017862038AP1994/05/31Labeling Revision
017862037AP1990/02/16Package Change
017862036AP1989/02/22Labeling Revision
017862035AP1992/08/31Control Supplement
017862033AP1988/09/12Manufacturing Change or Addition
017862032AP1987/09/15Labeling Revision
017862031AP1987/04/17Control Supplement
017862030AP1986/10/23Labeling Revision
017862029AP1987/05/28Package Change
017862026AP1985/11/20Manufacturing Change or Addition
017862025AP1985/10/21Labeling Revision
017862024AP1985/08/20Labeling Revision
017862022AP1985/03/12Labeling Revision
017862021AP1987/05/28New or Modified Indication
017862020AP1983/07/05General Efficacy (MarkIV)
017862019AP1983/06/14Manufacturing Change or Addition
017862018AP1984/08/03Manufacturing Change or Addition
017862017AP1983/04/13Labeling Revision
017862016AP1983/01/04Manufacturing Change or Addition
017862015AP1982/11/12Labeling Revision
017862014AP1982/11/02Formulation Revision
017862013AP1982/09/08Labeling Revision
017862012AP1982/06/23Manufacturing Change or Addition
017862010AP1982/05/27Manufacturing Change or Addition
017862009AP1982/02/19General Efficacy (MarkIV)
017862008AP1981/12/09Manufacturing Change or Addition
017862007AP1981/10/08Control Supplement
017862006AP1982/06/28General Efficacy (MarkIV)
017862005AP1980/01/25Control Supplement
017862004AP1979/12/28Labeling Revision
017862003AP1981/01/22General Efficacy (MarkIV)
017862002AP1979/10/16Control Supplement
017862001AP1979/10/01Labeling Revision
017862000AP1979/02/07Approval