药品注册申请号:018723
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 DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Yes No AB 1983/03/10 1983/03/10 Prescription
002 DEPAKOTE DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Yes Yes AB 1983/03/10 Prescription
003 DEPAKOTE DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Yes No AB 1984/10/26 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 61 Approval Labeling STANDARD
2018/03/06 SUPPL 60 Approval Labeling STANDARD
2017/10/05 SUPPL 59 Approval Labeling STANDARD
2017/03/06 SUPPL 58 Approval Labeling STANDARD
2016/11/02 SUPPL 57 Approval Labeling STANDARD
2016/02/18 SUPPL 56 Approval Labeling STANDARD
2015/09/23 SUPPL 55 Approval Labeling STANDARD
2015/03/13 SUPPL 54 Approval Labeling STANDARD
2015/01/07 SUPPL 51 Approval Labeling STANDARD
2014/11/20 SUPPL 50 Approval Labeling STANDARD
2014/08/20 SUPPL 53 Approval Labeling STANDARD
2014/06/19 SUPPL 41 Approval Labeling STANDARD
2014/06/09 SUPPL 52 Approval Labeling STANDARD
2013/07/31 SUPPL 48 Approval Labeling STANDARD
2013/06/14 SUPPL 49 Approval Labeling STANDARD
2013/02/27 SUPPL 47 Approval Labeling STANDARD
2011/10/07 SUPPL 46 Approval Labeling UNKNOWN
2011/10/07 SUPPL 45 Approval Labeling UNKNOWN
2011/10/07 SUPPL 43 Approval Labeling UNKNOWN
2011/10/07 SUPPL 40 Approval Labeling STANDARD
2011/10/07 SUPPL 37 Approval Labeling STANDARD
2009/04/23 SUPPL 39 Approval Labeling 901 REQUIRED
2006/10/13 SUPPL 33 Approval Labeling STANDARD
2006/01/11 SUPPL 32 Approval Labeling STANDARD
2002/12/12 SUPPL 29 Approval Labeling STANDARD
2002/12/09 SUPPL 31 Approval Manufacturing (CMC) STANDARD
2002/11/05 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2000/06/19 SUPPL 28 Approval Labeling STANDARD
1998/09/22 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1998/05/08 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1998/04/02 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1997/12/24 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1996/12/02 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1996/06/20 SUPPL 20 Approval Efficacy STANDARD
1996/03/18 SUPPL 17 Approval Efficacy STANDARD
1995/03/23 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1994/06/22 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1994/03/18 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1989/08/16 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1989/03/21 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1988/08/17 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1986/11/24 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1986/08/11 SUPPL 4 Approval Labeling
1986/08/11 SUPPL 2 Approval Labeling
1985/12/23 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1985/12/06 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1984/10/26 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1983/03/10 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 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 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**
002 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 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**
003 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 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**
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
与本品治疗等效的药品
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, DELAYED 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
018723 001 NDA DEPAKOTE DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription Yes No AB 1983/03/10 ABBVIE
077615 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 APOTEX
078182 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 UPSHER SMITH LABS
078290 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 SANDOZ
078597 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 SUN PHARM INDS
078755 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 DR REDDYS LABS LTD
078790 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/29 LUPIN
077296 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/07/31 CELLTRION
078853 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/11/25 ORCHID HLTHCARE
077100 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/03/05 ZYDUS PHARMS USA INC
090062 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/03/17 MYLAN
090210 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2009/11/30 PRINSTON INC
079163 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2011/04/05 UNICHEM LABS LTD
090554 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2011/04/21 AUROBINDO PHARMA LTD
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, DELAYED 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
018723 002 NDA DEPAKOTE DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription Yes Yes AB 1983/03/10 ABBVIE
077615 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 APOTEX
078182 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 UPSHER SMITH LABS
078290 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 SANDOZ
078597 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 SUN PHARM INDS
078755 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 DR REDDYS LABS LTD
078790 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/29 LUPIN
077296 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/07/31 CELLTRION
078411 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/11/03 ANCHEN PHARMS
078853 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/11/25 ORCHID HLTHCARE
077100 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/03/05 ZYDUS PHARMS USA INC
090062 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/03/17 MYLAN
090210 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2009/11/30 PRINSTON INC
079080 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2011/02/25 ACTAVIS LABS FL INC
079163 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2011/04/05 UNICHEM LABS LTD
090554 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2011/04/21 AUROBINDO PHARMA LTD
活性成分:DIVALPROEX SODIUM 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 125MG 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
018723 003 NDA DEPAKOTE DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription Yes No AB 1984/10/26 ABBVIE
077615 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 APOTEX
078182 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 UPSHER SMITH LABS
078290 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 SANDOZ
078597 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 SUN PHARM INDS
078755 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 DR REDDYS LABS LTD
078790 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/29 LUPIN
077296 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/07/31 CELLTRION
078853 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/11/25 ORCHID HLTHCARE
077100 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2009/03/05 ZYDUS PHARMS USA INC
090062 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2009/03/17 MYLAN
090210 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2009/11/30 PRINSTON INC
079163 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2011/04/05 UNICHEM LABS LTD
090554 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2011/04/21 AUROBINDO PHARMA LTD
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