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 |
|---|
| 2024/03/21 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/21 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/02/19 |
ORIG-1（原始申请） |
Approval |
|
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 | RLD | RS | TE 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 | RLD | RS | TE 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 |