药品名称PREMARIN
申请号004782产品号002
活性成分ESTROGENS, CONJUGATED市场状态停止上市
剂型或给药途径TABLET;ORAL规格2.5MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WYETH PHARMACEUTICALS INC
化学类型New molecular entity (NME)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
004782171APLetter2014/12/04下载
004782171APLabel2014/12/10下载
004782167APLabel2011/11/01下载
004782167APLetter2011/10/31下载
004782164APLetter2011/10/31下载
004782164APLabel2011/11/01下载
004782162APLetter2011/10/31下载
004782162APLabel2011/11/01下载
004782155APLabel2008/03/05下载
004782155APLetter2008/03/05下载
004782147APLabel2006/09/12下载
004782147APLetter2006/09/18下载
004782146APLabel2006/04/25下载
004782146APLetter2006/04/25下载
004782142APLetter2005/11/03下载
004782142APLabel2005/11/03下载
004782141APLabel2005/08/04下载
004782141APLetter2005/08/04下载
004782139APLabel2005/04/12下载
004782139APLetter2005/04/12下载
004782138APLabel2005/04/12下载
004782138APLetter2005/04/12下载
004782137APLetter2004/08/31下载
004782137APLabel2004/08/31下载
004782136APLabel2004/11/17下载
004782136APLetter2004/04/29下载
004782133APLetter2004/04/29下载
004782133APLabel2004/05/04下载
004782130APLabel2003/04/30下载
004782130APLetter2003/05/16下载
004782130APReview2007/04/09下载
004782129APLetter2003/01/07下载
004782129APLabel2003/01/07下载
004782128APLetter2002/11/27下载
004782128APLabel2002/11/27下载
004782125APLetter2003/07/28下载
004782115APLetter2003/05/16下载
004782115APLabel2003/04/28下载
004782115APReview2007/04/09下载
004782093APReview1998/09/08下载
004782093APLetter1998/09/08下载
004782000APOther Important Information from FDA2009/06/02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
004782173AP2015/09/01Manufacturing Change or Addition
004782172AP2015/06/09Manufacturing Change or Addition
004782171AP2014/12/03Labeling Revision
004782167AP2011/10/28Labeling Revision
004782164AP2011/10/28Labeling Revision
004782163AP2014/04/11Manufacturing Change or Addition
004782162AP2011/10/28Labeling Revision
004782155AP2008/03/03Labeling Revision
004782147AP2006/09/05Labeling Revision
004782146AP2006/04/24Labeling Revision
004782142AP2005/11/01Formulation Revision
004782141AP2005/08/01Formulation Revision
004782139AP2005/04/07Labeling Revision
004782138AP2005/04/07Labeling Revision
004782137AP2004/08/26Formulation Revision
004782136AP2004/04/20Labeling Revision
004782133AP2004/04/20Labeling Revision
004782130AP2003/04/24Labeling Revision
004782129AP2003/01/07Labeling Revision
004782128AP2002/11/27Labeling Revision
004782126AP2002/12/20Control Supplement
004782125AP2003/07/16Labeling Revision
004782124AP2002/08/21Control Supplement
004782121AP2001/12/03Control Supplement
004782120AP2001/08/06Control Supplement
004782116AP2001/04/24Expiration Date Change
004782115AP2003/04/24New Dosage Regimen
004782113AP2000/07/05Control Supplement
004782109AP1999/06/08Labeling Revision
004782108AP1998/10/29Control Supplement
004782104AP1998/05/06Labeling Revision
004782103AP1996/06/28Control Supplement
004782102AP1996/06/27Control Supplement
004782101AP1998/02/27Control Supplement
004782100AP1995/12/14Control Supplement
004782099AP1995/12/13Control Supplement
004782098AP1995/04/11Control Supplement
004782096AP1998/05/06Labeling Revision
004782095AP1995/02/06Manufacturing Change or Addition
004782094AP1994/11/09Control Supplement
004782093AP1998/09/08New Dosage Regimen
004782092AP1993/12/23Labeling Revision
004782087AP1992/03/11Package Change
004782086AP1999/04/26Control Supplement
004782083AP1990/02/23Formulation Revision
004782081AP1989/12/22Labeling Revision
004782079AP1989/05/19Labeling Revision
004782078AP1991/05/09Expiration Date Change
004782077AP1991/05/14Control Supplement
004782075AP1989/05/19Labeling Revision
004782074AP1989/02/03Formulation Revision
004782073AP1988/12/20Package Change
004782072AP1989/05/19Labeling Revision
004782071AP1988/04/17Control Supplement
004782070AP1987/05/14Manufacturing Change or Addition
004782068AP1987/10/16Control Supplement
004782066AP1986/09/24Manufacturing Change or Addition
004782065AP1986/12/03Control Supplement
004782064AP1989/05/19Labeling Revision
004782063AP1986/07/10Control Supplement
004782062AP1986/05/12Control Supplement
004782061AP1989/05/19Labeling Revision
004782060AP1986/01/07Formulation Revision
004782059AP1985/10/25Package Change
004782058AP1985/09/30Control Supplement
004782057AP1986/05/28Labeling Revision
004782054AP1985/04/29Labeling Revision
004782053AP1985/04/29Labeling Revision
004782052AP1985/05/29Control Supplement
004782051AP1985/04/29Labeling Revision
004782050AP1985/05/29Package Change
004782049AP1984/01/26Formulation Revision
004782000AP1942/05/08Approval