药品注册申请号:021168
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 DEPAKOTE ER DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Yes Yes AB 2000/08/04 2000/08/04 Prescription
002 DEPAKOTE ER DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Yes No AB 2002/05/31 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/02/21 SUPPL 39 Approval Labeling STANDARD
2018/03/06 SUPPL 38 Approval Labeling STANDARD
2017/10/05 SUPPL 37 Approval Labeling STANDARD
2017/03/06 SUPPL 36 Approval Labeling STANDARD
2016/11/02 SUPPL 35 Approval Labeling STANDARD
2016/05/12 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2016/02/18 SUPPL 33 Approval Labeling STANDARD
2015/09/23 SUPPL 32 Approval Labeling STANDARD
2015/03/20 SUPPL 30 Approval Labeling STANDARD
2015/03/13 SUPPL 31 Approval Labeling STANDARD
2015/01/07 SUPPL 27 Approval Labeling STANDARD
2014/11/20 SUPPL 26 Approval Labeling STANDARD
2014/08/20 SUPPL 29 Approval Labeling STANDARD
2014/06/19 SUPPL 19 Approval Labeling STANDARD
2014/06/09 SUPPL 28 Approval Labeling STANDARD
2013/07/31 SUPPL 24 Approval Labeling STANDARD
2013/06/14 SUPPL 25 Approval Labeling STANDARD
2013/02/27 SUPPL 23 Approval Labeling STANDARD
2011/10/07 SUPPL 22 Approval Labeling UNKNOWN
2011/10/07 SUPPL 20 Approval Labeling UNKNOWN
2011/10/07 SUPPL 17 Approval Labeling STANDARD
2011/10/07 SUPPL 16 Approval Labeling STANDARD
2009/04/23 SUPPL 18 Approval Labeling 901 REQUIRED
2008/03/24 SUPPL 15 Approval Efficacy PRIORITY
2006/10/13 SUPPL 14 Approval Labeling STANDARD
2006/01/11 SUPPL 9 Approval Labeling STANDARD
2005/12/06 SUPPL 12 Approval Efficacy STANDARD
2003/08/14 SUPPL 7 Approval Efficacy PRIORITY
2003/04/20 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2002/12/20 SUPPL 4 Approval Labeling STANDARD
2002/12/12 SUPPL 3 Approval Labeling STANDARD
2002/05/31 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2000/08/04 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 6419953*PED 2019/06/18 PDF格式
6511678*PED 2019/06/18 PDF格式
6528090*PED 2019/06/18 PDF格式
6528091*PED 2019/06/18 PDF格式
6713086*PED 2019/06/18 PDF格式
6720004*PED 2019/06/18 PDF格式
002 6511678*PED 2019/06/18 PDF格式
6528090*PED 2019/06/18 PDF格式
6713086*PED 2019/06/18 PDF格式
6720004*PED 2019/06/18 PDF格式
001 4913906 2007/04/03 PDF格式**本条是由Drugfuture回溯的历史信息**
4988731 2008/01/29 PDF格式**本条是由Drugfuture回溯的历史信息**
4988731*PED 2008/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
5212326 2008/01/29 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5212326*PED 2008/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
6419953 2018/12/18 PDF格式**本条是由Drugfuture回溯的历史信息**
6511678 2018/12/18 PDF格式**本条是由Drugfuture回溯的历史信息**
6528090 2018/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6528091 2018/12/18 U-106 PDF格式**本条是由Drugfuture回溯的历史信息**
6713086 2018/12/18 Y U-579 PDF格式**本条是由Drugfuture回溯的历史信息**
6720004 2018/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 4913906 2007/04/03 PDF格式**本条是由Drugfuture回溯的历史信息**
4988731 2008/01/29 PDF格式**本条是由Drugfuture回溯的历史信息**
4988731*PED 2008/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
5212326 2008/01/29 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5212326*PED 2008/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
6511678 2018/12/18 PDF格式**本条是由Drugfuture回溯的历史信息**
6528090 2018/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6713086 2018/12/18 Y U-579 PDF格式**本条是由Drugfuture回溯的历史信息**
6720004 2018/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
001 I-482 2008/12/06**本条是由Drugfuture回溯的历史信息**
M-34 2011/03/24**本条是由Drugfuture回溯的历史信息**
PED 2009/06/06**本条是由Drugfuture回溯的历史信息**
PED 2011/09/24**本条是由Drugfuture回溯的历史信息**
002 I-482 2008/12/06**本条是由Drugfuture回溯的历史信息**
M-34 2011/03/24**本条是由Drugfuture回溯的历史信息**
PED 2009/06/06**本条是由Drugfuture回溯的历史信息**
PED 2011/09/24**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 500MG VALPROIC ACID 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
209286 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No AB -- LUPIN LTD
021168 001 NDA DEPAKOTE ER DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription Yes Yes AB 2000/08/04 ABBVIE
077567 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/01/29 MYLAN
078239 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/08/04 ZYDUS PHARMS USA INC
078705 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/08/04 WOCKHARDT
078791 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/08/04 IMPAX LABS
090070 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2012/03/12 REDDYS
202419 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2014/06/02 AUROBINDO PHARMA LTD
203730 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2015/05/29 AMNEAL PHARMS
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:EQ 250MG VALPROIC ACID 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
209286 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No AB -- LUPIN LTD
021168 002 NDA DEPAKOTE ER DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription Yes No AB 2002/05/31 ABBVIE
077567 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/01/29 MYLAN
078705 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/02/10 WOCKHARDT
078239 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/02/27 ZYDUS PHARMS USA INC
078791 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/05/06 IMPAX LABS
090161 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2012/03/15 DR REDDYS LABS LTD
202419 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2014/06/02 AUROBINDO PHARMA LTD
203730 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2015/05/29 AMNEAL PHARMS
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