药品注册申请号:020607
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Yes No AB 1997/12/24 1997/12/24 Prescription
002 ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Yes Yes AB 1997/12/24 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
2022/12/22 SUPPL-41(补充) Approval Labeling STANDARD
2022/08/26 SUPPL-40(补充) Approval Labeling STANDARD
2021/08/02 SUPPL-39(补充) Approval Labeling STANDARD
2021/04/28 SUPPL-38(补充) Approval Labeling STANDARD
2020/09/24 SUPPL-36(补充) Approval Labeling STANDARD
2020/07/28 SUPPL-33(补充) Approval Labeling STANDARD
2016/05/09 SUPPL-31(补充) Approval Labeling STANDARD
2015/04/01 SUPPL-21(补充) Approval Labeling STANDARD
2014/09/03 SUPPL-28(补充) Approval Labeling STANDARD
2013/03/07 SUPPL-25(补充) Approval Labeling STANDARD
2013/02/08 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
2010/12/21 SUPPL-16(补充) Approval Labeling UNKNOWN
2009/09/11 SUPPL-13(补充) Approval Labeling STANDARD
2009/02/25 SUPPL-14(补充) Approval Labeling 901 REQUIRED
2007/08/24 SUPPL-10(补充) Approval Labeling STANDARD
2006/01/25 SUPPL-9(补充) Approval Labeling STANDARD
2005/07/08 SUPPL-8(补充) Approval Labeling STANDARD
2002/05/20 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/10/03 SUPPL-5(补充) Approval Labeling STANDARD
1999/02/22 SUPPL-4(补充) Approval Labeling STANDARD
1998/07/20 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1998/04/15 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1998/03/16 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1997/12/24 ORIG-1(原始申请) Approval Type 4 - New Combination 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 5601843 2014/02/11 PDF格式**本条是由Drugfuture回溯的历史信息**
5698225 2010/05/03 U-392 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5601843 2014/02/11 PDF格式**本条是由Drugfuture回溯的历史信息**
5698225 2010/05/03 U-392 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:DICLOFENAC SODIUM; MISOPROSTOL 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:50MG;0.2MG 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
020607 001 NDA ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription Yes No AB 1997/12/24 PFIZER
201089 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription No No AB 2012/07/09 ACTAVIS LABS FL INC
200158 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Discontinued No No AB 2013/05/09 SANDOZ
203995 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription No No AB 2016/11/25 AMNEAL PHARMS
205143 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription No No AB 2020/02/19 YUNG SHIN PHARM
204355 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Prescription No No AB 2021/07/15 MICRO LABS
206771 001 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG Discontinued No No AB 2023/06/12 ZYDUS PHARMS
活性成分:DICLOFENAC SODIUM; MISOPROSTOL 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:75MG;0.2MG 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
020607 002 NDA ARTHROTEC DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription Yes Yes AB 1997/12/24 PFIZER
201089 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription No No AB 2012/07/09 ACTAVIS LABS FL INC
200158 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Discontinued No No AB 2013/05/09 SANDOZ
203995 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription No No AB 2016/11/25 AMNEAL PHARMS
205143 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription No No AB 2020/02/19 YUNG SHIN PHARM
204355 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Prescription No No AB 2021/07/15 MICRO LABS
206771 002 ANDA DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG Discontinued No No AB 2023/06/12 ZYDUS PHARMS
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