药品注册申请号:077567
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS 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, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID No No AB 2009/01/29 2009/01/29 Prescription
002 DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID No No AB 2009/01/29 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
2023/10/23 SUPPL-34(补充) Approval Labeling STANDARD
2023/10/23 SUPPL-32(补充) Approval Labeling STANDARD
2023/10/23 SUPPL-29(补充) Approval Labeling STANDARD
2023/10/23 SUPPL-28(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-26(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-24(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-20(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-19(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-17(补充) Approval Labeling STANDARD
2020/01/03 SUPPL-14(补充) Approval Labeling STANDARD
2015/09/22 SUPPL-13(补充) Approval Labeling STANDARD
2015/09/22 SUPPL-12(补充) Approval Labeling STANDARD
2015/09/22 SUPPL-11(补充) Approval Labeling STANDARD
2014/09/13 SUPPL-10(补充) Approval Labeling STANDARD
2014/09/13 SUPPL-9(补充) Approval Labeling STANDARD
2014/09/13 SUPPL-8(补充) Approval Labeling STANDARD
2010/09/10 SUPPL-5(补充) Approval Labeling
2009/01/29 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
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
002 PC 2009/08/01**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 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
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
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
209286 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2019/10/18 LUPIN LTD
214643 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2022/02/25 UNICHEM
215527 001 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 250MG VALPROIC ACID Prescription No No AB 2023/09/26 ANNORA PHARMA
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
021168 001 NDA DEPAKOTE ER DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription Yes No 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
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 Yes AB 2015/05/29 AMNEAL PHARMS
209286 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2019/10/18 LUPIN LTD
214643 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2022/02/25 UNICHEM
215527 002 ANDA DIVALPROEX SODIUM DIVALPROEX SODIUM TABLET, EXTENDED RELEASE;ORAL EQ 500MG VALPROIC ACID Prescription No No AB 2023/09/26 ANNORA PHARMA
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