药品名称ACCUTANE
申请号018662产品号002
活性成分ISOTRETINOIN市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格10MG
治疗等效代码参比药物
批准日期1982/05/07申请机构HOFFMANN LA ROCHE INC
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
018662061APMedication Guide2010/10/25下载
018662061APLetter2010/10/26下载
018662060APLabel2010/02/04下载
018662060APLetter2010/02/05下载
018662059APLetter2008/11/21下载
018662059APLabel2009/06/10下载
018662058APLetter2007/10/10下载
018662058APLabel2007/10/10下载
018662057APReview2007/07/06下载
018662056APLabel2005/08/12下载
018662056APLetter2005/08/15下载
018662056APReview2007/07/06下载
018662055APReview2007/07/06下载
018662054APLetter2004/08/25下载
018662054APLabel2004/08/25下载
018662054APReview2007/07/06下载
018662053APReview2007/07/06下载
018662052APReview2007/07/06下载
018662052APLabel2003/08/29下载
018662052APLetter2004/05/25下载
018662051APLetter2002/06/20下载
018662051APLabel2002/06/20下载
018662048APLetter2003/08/27下载
018662048APLabel2003/08/29下载
018662048APReview2007/07/06下载
018662047APLetter2002/04/12下载
018662047APPatient Package Insert2002/04/12下载
018662046APLetter2002/02/15下载
018662046APLabel2002/02/15下载
018662045APLetter2001/12/31下载
018662045APLabel2001/12/31下载
018662044APLetter2001/10/30下载
018662044APLabel2001/10/30下载
018662043APLetter2002/05/02下载
018662043APLabel2002/05/02下载
018662042APReview2007/07/06下载
018662041APLetter2001/12/31下载
018662041APLabel2001/12/31下载
018662040APLetter2000/05/01下载
018662039APLetter2000/05/01下载
018662038APLetter2000/05/01下载
018662038APReview2007/07/06下载
018662000APOther Important Information from FDA2005/07/28下载
018662000APMedication Guide2010/02/17下载
018662000APOther2015/07/02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
018662061AP2010/10/22Labeling Revision
018662060AP2010/02/01Labeling Revision
018662059AP2008/11/19Labeling Revision
018662058AP2007/10/03Labeling Revision
018662057AP2006/01/13Supplement
018662056AP2005/08/12Labeling Revision
018662055AP2005/08/10Supplement
018662054AP2004/08/24Labeling Revision
018662053AP2004/03/26Manufacturing Change or Addition
018662052AP2003/08/27Labeling Revision
018662051AP2002/06/20Labeling Revision
018662048AP2003/08/27Labeling Revision
018662047AP2002/04/12Labeling Revision
018662046AP2002/02/15Labeling Revision
018662045AP2001/12/31Labeling Revision
018662044AP2001/10/30Labeling Revision
018662043AP2002/05/02Efficacy Supplement with Clinical Data to Support
018662042AP2001/01/11Control Supplement
018662041AP2001/12/31Labeling Revision
018662040AP2000/05/01Labeling Revision
018662039AP2000/05/01Labeling Revision
018662038AP2000/05/01Labeling Revision
018662037AP1999/04/30Package Change
018662034AP1995/05/17Labeling Revision
018662033AP1994/01/13Labeling Revision
018662032AP1991/10/08Control Supplement
018662031AP1990/10/16Package Change
018662030AP1991/03/07Labeling Revision
018662029AP1990/04/16Labeling Revision
018662028AP1989/08/09Package Change
018662027AP1989/04/04Manufacturing Change or Addition
018662026AP1989/04/28Package Change
018662025AP1988/11/16Package Change
018662024AP1988/08/26Labeling Revision
018662023AP1988/01/07Expiration Date Change
018662022AP1987/10/19Labeling Revision
018662021AP1987/06/03Control Supplement
018662020AP1987/06/01Labeling Revision
018662019AP1987/02/26Package Change
018662018AP1986/06/06Labeling Revision
018662017AP1986/06/06Labeling Revision
018662016AP1985/07/05Labeling Revision
018662015AP1985/04/30Labeling Revision
018662014AP1986/06/06New Dosage Regimen
018662013AP1984/11/27Control Supplement
018662011AP1984/11/01Manufacturing Change or Addition
018662010AP1986/06/06Labeling Revision
018662009AP1984/05/31Package Change
018662008AP1984/02/28Labeling Revision
018662007AP1985/06/19Control Supplement
018662004AP1983/08/09Labeling Revision
018662003AP1986/06/06Labeling Revision
018662002AP1983/06/30Manufacturing Change or Addition
018662001AP1986/06/06Labeling Revision
018662000AP1982/05/07Approval