药品名称ZOCOR
申请号019766产品号004
活性成分SIMVASTATIN市场状态处方药
剂型或给药途径TABLET;ORAL规格40MG
治疗等效代码AB参比药物
批准日期1991/12/23申请机构MERCK RESEARCH LABORATORIES DIV MERCK CO 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
019766093APLetter2015/02/03下载
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019766091APLetter2014/02/28下载
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019766090APLetter2013/10/28下载
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019766085APLetter2012/02/29下载
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019766083APReview2012/06/06下载
019766083APLetter2011/10/12下载
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019766082APLabel2011/06/08下载
019766082APLetter2011/06/08下载
019766081APLetter2010/11/08下载
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019766080APLetter2010/04/13下载
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019766079APLetter2011/06/17下载
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019766078APLetter2010/03/08下载
019766077APReview2011/08/15下载
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019766069APLetter2005/09/08下载
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019766067APLetter2004/02/25下载
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019766056APLetter2002/10/18下载
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019766055APReview2008/02/19下载
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019766050APReview2008/02/19下载
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019766044APReview2007/11/19下载
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019766040APLetter2000/04/27下载
019766040APReview2000/04/27下载
019766040APLabel2000/04/27下载
019766036APReview1999/11/22下载
019766035APReview2008/04/04下载
019766034APReview1999/11/22下载
019766033APReview2008/02/19下载
019766032APLetter1999/08/05下载
019766031APReview2008/04/04下载
019766030APReview2008/02/19下载
019766029APReview1998/06/29下载
019766028APLetter1998/07/10下载
019766028APReview1998/07/10下载
019766027APLetter1998/03/31下载
019766027APReview1998/03/31下载
019766026APLetter1998/07/10下载
019766026APReview1998/07/10下载
019766025APReview2008/02/19下载
019766023APReview2008/02/19下载
019766022APReview2008/02/19下载
019766018APReview1997/05/19下载
019766016APReview2008/02/19下载
019766014APReview2008/04/04下载
019766012APReview2008/04/04下载
019766008APReview2008/04/04下载
019766000APOther Important Information from FDA2008/01/25下载
019766000APOther2007/07/09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
019766095AP2016/03/01Manufacturing Change or Addition
019766093AP2015/02/02Labeling Revision
019766091AP2014/02/27Labeling Revision
019766090AP2013/10/25Labeling Revision
019766088AP2012/10/31Labeling Revision
019766087AP2012/10/31Labeling Revision
019766086AP2012/11/15Manufacturing Change or Addition
019766085AP2012/02/28Labeling Revision
019766083AP2011/10/06Labeling Revision
019766082AP2011/06/08Labeling Revision
019766081AP2010/11/04Labeling Revision
019766080AP2010/04/08Labeling Revision
019766079AP2011/06/10Labeling Revision
019766078AP2010/03/02Labeling Revision
019766077AP2011/06/08Labeling Revision
019766076AP2008/06/11Labeling Revision
019766075AP2007/11/26Labeling Revision
019766074AP2007/06/01Control Supplement
019766070AP2005/05/17Labeling Revision
019766069AP2005/08/31Labeling Revision
019766068AP2004/02/25Supplement
019766067AP2004/02/24Labeling Revision
019766066AP2003/09/17Labeling Revision
019766065AP2003/09/17Labeling Revision
019766058AP2003/04/16New or Modified Indication
019766057AP2002/05/06Control Supplement
019766056AP2002/10/18Patient Population Altered
019766055AP2002/02/22Manufacturing Change or Addition
019766054AP2002/03/21Package Change
019766053AP2001/11/14Labeling Revision
019766052AP2002/03/21Efficacy Supplement with Clinical Data to Support
019766051AP2002/05/06Labeling Revision
019766050AP2001/09/13Control Supplement
019766049AP2001/06/04Control Supplement
019766048AP2001/04/10Manufacturing Change or Addition
019766047AP2001/04/10Manufacturing Change or Addition
019766045AP2001/11/14Labeling Revision
019766044AP2000/12/11Package Change
019766043AP2000/04/14Manufacturing Change or Addition
019766042AP2000/11/07Efficacy Supplement with Clinical Data to Support
019766041AP2000/03/15Control Supplement
019766040AP2000/04/27New Dosage Regimen
019766039AP2000/08/22Labeling Revision
019766036AP1999/11/22New or Modified Indication
019766035AP1999/09/15Labeling Revision
019766034AP1999/11/22New or Modified Indication
019766033AP1999/03/22Expiration Date Change
019766032AP1999/08/05New or Modified Indication
019766031AP1999/04/23Labeling Revision
019766030AP1998/09/24Manufacturing Change or Addition
019766029AP1998/06/29Labeling Revision
019766028AP1998/07/10New Dosage Regimen
019766027AP1998/03/31New or Modified Indication
019766026AP1998/07/10New or Modified Indication
019766025AP1997/12/02Control Supplement
019766023AP1997/09/09Control Supplement
019766022AP1997/07/18Manufacturing Change or Addition
019766021AP1997/10/31New or Modified Indication
019766020AP1997/08/12Labeling Revision
019766019AP1997/03/17Control Supplement
019766018AP1997/05/19Labeling Revision
019766017AP1997/05/23Labeling Revision
019766016AP1996/11/22Control Supplement
019766015AP1995/08/01Labeling Revision
019766014AP1995/06/09Labeling Revision
019766013AP1995/11/06Control Supplement
019766012AP1995/08/01Control Supplement
019766011AP1995/06/30New or Modified Indication
019766010AP1995/02/16Labeling Revision
019766009AP1994/12/21Labeling Revision
019766008AP1995/04/19Labeling Revision
019766007AP1994/07/28Manufacturing Change or Addition
019766006AP1995/01/23Labeling Revision
019766005AP1994/02/22Labeling Revision
019766004AP1993/11/24Package Change
019766003AP1994/02/22Labeling Revision
019766002AP1993/08/09Package Change
019766001AP1992/11/27Labeling Revision
019766000AP1991/12/23Approval