药品注册申请号：077100
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS USA INC
申请人全名：ZYDUS PHARMACEUTICALS USA 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 DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID No No AB 2009/03/05 2009/03/05 Prescription
002 DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID No No AB 2009/03/05 Prescription
003 DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID No No AB 2009/03/05 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2020/01/09 SUPPL-30（补充） Approval Labeling STANDARD
2020/01/09 SUPPL-29（补充） Approval Labeling STANDARD
2020/01/09 SUPPL-28（补充） Approval Labeling STANDARD
2020/01/09 SUPPL-26（补充） Approval Labeling STANDARD
2020/01/09 SUPPL-25（补充） Approval Labeling STANDARD
2020/01/09 SUPPL-22（补充） Approval Labeling STANDARD
2015/11/30 SUPPL-20（补充） Approval Labeling STANDARD
2015/11/30 SUPPL-17（补充） Approval Labeling STANDARD
2015/02/17 SUPPL-16（补充） Approval Labeling STANDARD
2015/02/17 SUPPL-14（补充） Approval Labeling STANDARD
2014/09/13 SUPPL-13（补充） Approval Labeling STANDARD
2014/09/13 SUPPL-12（补充） Approval Labeling STANDARD
2014/09/13 SUPPL-6（补充） Approval Labeling STANDARD
2014/09/13 SUPPL-5（补充） Approval Labeling STANDARD
2014/09/13 SUPPL-3（补充） Approval Labeling STANDARD
2010/01/14 SUPPL-1（补充） Approval Labeling
2009/03/05 ORIG-1（原始申请） Approval
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
无
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
无
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 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 INVATECH
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 CHARTWELL RX
078853 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 125MG VALPROIC ACID Prescription No No AB 2008/11/25 ORBION PHARMS
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
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
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 INVATECH
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 CHARTWELL RX
078853 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2008/11/25 ORBION PHARMS
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
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 INVATECH
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 CHARTWELL RX
078853 003 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, DELAYED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2008/11/25 ORBION PHARMS
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
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 Discontinued 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
更多信息
药品NDC数据与药品包装、标签说明书
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