药品名称REGLAN
申请号017854产品号001
活性成分METOCLOPRAMIDE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 10MG BASE
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ANI PHARMACEUTICALS INC
化学类型New dosage form审评分类Standard 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
017854058APLabel2011/09/23下载
017854058APLetter2011/09/26下载
017854056APLetter2011/08/05下载
017854055APLetter2010/11/22下载
017854055APLabel2010/11/26下载
017854055APMedication Guide2010/11/26下载
017854052APMedication Guide2009/09/21下载
017854052APLabel2009/10/08下载
017854052APLetter2009/10/26下载
017854051APLabel2009/09/22下载
017854051APReview2011/01/04下载
017854051APLetter2009/07/06下载
017854047APLetter2004/07/28下载
017854047APLabel2004/07/28下载
017854045APLetter2003/05/29下载
017854044APLetter2003/05/29下载
017854041APLetter2002/11/25下载
017854040APLetter2003/05/29下载
017854039APReview2001/06/18下载
017854000APMedication Guide2011/12/20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
017854061AP2015/06/15Manufacturing Change or Addition
017854060AP2015/04/17Manufacturing Change or Addition
017854059AP2015/01/12Manufacturing Change or Addition
017854058AP2011/09/22Labeling Revision
017854056AP2011/08/02Labeling Revision
017854055AP2010/11/18Labeling Revision
017854052AP2009/09/04Labeling Revision
017854051AP2009/06/30Labeling Revision
017854047AP2004/07/26Labeling Revision
017854045AP2003/04/22Labeling Revision
017854044AP2003/04/22Labeling Revision
017854041AP2001/11/07Labeling Revision
017854040AP2003/04/22Labeling Revision
017854039AP1999/03/09Labeling Revision
017854038AP1998/02/03Manufacturing Change or Addition
017854037AP2000/06/01Labeling Revision
017854036AP1996/06/24Labeling Revision
017854035AP1994/05/31Labeling Revision
017854034AP1989/02/22Labeling Revision
017854033AP1992/08/31Control Supplement
017854031AP1988/09/12Manufacturing Change or Addition
017854030AP1986/10/21Labeling Revision
017854029AP1987/05/05Formulation Revision
017854028AP1986/04/15Package Change
017854027AP1986/04/23Labeling Revision
017854026AP1986/01/16Control Supplement
017854025AP1985/10/21Labeling Revision
017854024AP1985/08/20Labeling Revision
017854022AP1985/01/18Package Change
017854021AP1985/03/12Labeling Revision
017854020AP1984/09/21Control Supplement
017854019AP1984/05/01Labeling Revision
017854018AP1984/05/01Package Change
017854017AP1983/07/05Labeling Revision
017854016AP1983/05/11Control Supplement
017854015AP1983/04/13Labeling Revision
017854014AP1982/11/12Labeling Revision
017854013AP1982/09/08Labeling Revision
017854012AP1983/07/27Formulation Revision
017854011AP1982/09/23Control Supplement
017854010AP1982/02/25Control Supplement
017854009AP1982/02/19Manufacturing Change or Addition
017854008AP1981/12/09Manufacturing Change or Addition
017854007AP1982/02/18Package Change
017854006AP1981/11/06Package Change
017854005AP1984/08/15General Efficacy (MarkIV)
017854004AP1981/05/13Control Supplement
017854003AP1981/05/13Manufacturing Change or Addition
017854002AP1982/06/28General Efficacy (MarkIV)
017854001AP1981/05/13Package Change
017854000AP1980/12/30Approval