药品注册申请号：200158
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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 DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 50MG;0.2MG No No AB 2013/05/09 2013/05/09 Discontinued
002 DICLOFENAC SODIUM AND MISOPROSTOL DICLOFENAC SODIUM; MISOPROSTOL TABLET, DELAYED RELEASE;ORAL 75MG;0.2MG No No AB 2013/05/09 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2013/05/09 ORIG-1（原始申请） Approval Not Applicable
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2023/05/19 SUPPL-14（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-13（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-12（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-10（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-8（补充） Approval Labeling-Package Insert STANDARD
2023/05/19 SUPPL-7（补充） Approval Labeling-Package Insert 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
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: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
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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