药品注册申请号:019680
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 CAPSULE, DELAYED REL PELLETS;ORAL EQ 125MG VALPROIC ACID Yes Yes AB 1989/09/12 1989/09/12 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 48 Approval Labeling STANDARD
2018/03/06 SUPPL 47 Approval Labeling STANDARD
2017/10/05 SUPPL 46 Approval Labeling STANDARD
2017/03/06 SUPPL 45 Approval Labeling STANDARD
2016/11/02 SUPPL 44 Approval Labeling STANDARD
2016/02/18 SUPPL 43 Approval Labeling STANDARD
2015/09/23 SUPPL 42 Approval Labeling STANDARD
2015/03/13 SUPPL 41 Approval Labeling STANDARD
2015/01/07 SUPPL 38 Approval Labeling STANDARD
2014/11/20 SUPPL 37 Approval Labeling STANDARD
2014/08/20 SUPPL 40 Approval Labeling STANDARD
2014/06/20 SUPPL 33 Approval Labeling UNKNOWN
2014/06/19 SUPPL 28 Approval Labeling STANDARD
2014/06/09 SUPPL 39 Approval Labeling STANDARD
2013/07/31 SUPPL 35 Approval Labeling STANDARD
2013/06/14 SUPPL 36 Approval Labeling STANDARD
2013/02/27 SUPPL 34 Approval Labeling STANDARD
2011/10/07 SUPPL 31 Approval Labeling UNKNOWN
2011/10/07 SUPPL 29 Approval Labeling UNKNOWN
2011/10/07 SUPPL 27 Approval Labeling STANDARD
2011/10/07 SUPPL 25 Approval Labeling STANDARD
2009/04/23 SUPPL 26 Approval Labeling 901 REQUIRED
2008/03/24 SUPPL 24 Approval Efficacy PRIORITY
2006/12/19 SUPPL 21 Approval Labeling STANDARD
2006/10/13 SUPPL 22 Approval Labeling STANDARD
2006/01/11 SUPPL 19 Approval Labeling STANDARD
2002/12/12 SUPPL 15 Approval Labeling STANDARD
2002/11/05 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/06/19 SUPPL 14 Approval Labeling STANDARD
1998/05/08 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1996/12/02 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1996/06/20 SUPPL 8 Approval Efficacy STANDARD
1996/04/26 SUPPL 10 Approval Labeling STANDARD
1995/03/23 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1993/01/14 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1989/09/12 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**
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 M-34 2011/03/24**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:CAPSULE, DELAYED REL PELLETS;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
019680 001 NDA DEPAKOTE DIVALPROEX SODIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 125MG VALPROIC ACID Prescription Yes Yes AB 1989/09/12 ABBVIE
078979 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2009/01/23 DR REDDYS LABS LTD
078919 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2009/01/27 ZYDUS PHARMS USA INC
090407 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM CAPSULE, DELAYED REL PELLETS;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2011/03/28 MYLAN
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