药品名称DEPAKOTE
申请号018723产品号002
活性成分DIVALPROEX SODIUM市场状态处方药
剂型或给药途径TABLET, DELAYED RELEASE;ORAL规格EQ 500MG VALPROIC ACID
治疗等效代码AB参比药物
批准日期1983/03/10申请机构ABBVIE 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
49887312008/01/29PDF格式
4988731*PED2008/07/29PDF格式
52123262008/01/29PDF格式
5212326*PED2008/07/29PDF格式
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
018723056APLetter2016/02/23下载
018723056APLabel2016/02/23下载
018723055APLetter2015/09/25下载
018723055APLabel2015/10/06下载
018723054APLetter2015/03/17下载
018723054APLabel2015/03/17下载
018723053APLetter2014/08/21下载
018723053APLabel2014/08/22下载
018723052APLabel2014/06/10下载
018723052APLetter2014/06/11下载
018723051APLetter2015/01/08下载
018723051APLabel2015/01/08下载
018723050APLetter2014/11/24下载
018723050APLabel2014/12/03下载
018723049APLabel2013/07/02下载
018723048APLetter2013/09/17下载
018723048APLabel2013/09/17下载
018723047APLetter2013/03/01下载
018723047APLabel2013/03/04下载
018723046APLabel2011/10/12下载
018723046APLetter2011/10/13下载
018723045APLetter2011/10/13下载
018723045APLabel2011/10/12下载
018723043APLabel2011/10/12下载
018723043APLetter2011/10/13下载
018723041APLetter2014/06/23下载
018723041APLabel2014/06/23下载
018723040APLetter2011/10/13下载
018723040APLabel2011/10/12下载
018723039APLetter2009/05/01下载
018723039APLabel2009/05/12下载
018723037APLabel2011/10/12下载
018723037APLetter2011/10/13下载
018723033APLabel2006/10/18下载
018723033APLetter2006/10/23下载
018723032APLabel2006/01/13下载
018723032APLetter2006/01/20下载
018723029APLetter2004/06/02下载
018723000APOther Important Information from FDA2008/02/01下载
018723000APMedication Guide2013/03/08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
018723056AP2016/02/19Labeling Revision
018723055AP2015/09/23Labeling Revision
018723054AP2015/03/13Labeling Revision
018723053AP2014/08/20Labeling Revision
018723052AP2014/06/09Labeling Revision
018723051AP2015/01/07Labeling Revision
018723050AP2014/11/20Labeling Revision
018723049AP2013/06/14Labeling Revision
018723048AP2013/07/31Labeling Revision
018723047AP2013/02/27Labeling Revision
018723046AP2011/10/07Labeling Revision
018723045AP2011/10/07Labeling Revision
018723043AP2011/10/07Labeling Revision
018723041AP2014/06/19Labeling Revision
018723040AP2011/10/07Labeling Revision
018723039AP2009/04/23Labeling Revision
018723037AP2011/10/07Labeling Revision
018723033AP2006/10/13Labeling Revision
018723032AP2006/01/11Labeling Revision
018723031AP2002/12/09Control Supplement
018723030AP2002/11/05Control Supplement
018723029AP2002/12/12Labeling Revision
018723028AP2000/06/19Labeling Revision
018723027AP1998/09/22Control Supplement
018723026AP1998/04/02Manufacturing Change or Addition
018723025AP1998/05/08Package Change
018723024AP1997/12/24Formulation Revision
018723022AP1996/12/02Control Supplement
018723020AP1996/06/20New or Modified Indication
018723019AP1995/03/23Control Supplement
018723017AP1996/03/18New or Modified Indication
018723015AP1994/06/22Control Supplement
018723013AP1994/03/18Manufacturing Change or Addition
018723012AP1989/08/16Manufacturing Change or Addition
018723011AP1989/03/21Expiration Date Change
018723009AP1988/08/17Control Supplement
018723008AP1986/11/24Expiration Date Change
018723005AP1985/12/23Expiration Date Change
018723004AP1986/08/11Labeling Revision
018723003AP1985/12/06Control Supplement
018723002AP1986/08/11Labeling Revision
018723001AP1984/10/26Formulation Revision
018723000AP1983/03/10Approval