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 |
2024/11/21 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/04/29 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/09/02 |
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 剂型/给药途径:SOLUTION;TOPICAL 规格:1.5% 治疗等效代码:AT
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 |
202852 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2014/11/24
|
WATSON LABS INC |
203818 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
Yes |
AT |
2014/11/26
|
TARO |
202769 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Discontinued |
No |
No |
AT |
2015/07/08
|
PAI HOLDINGS PHARM |
204132 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2015/08/20
|
LUPIN LTD |
205878 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2015/12/09
|
NOVEL LABS INC |
206116 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2016/09/02
|
AMNEAL PHARMS |
206411 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2018/04/17
|
ZYDUS LIFESCIENCES |
206655 |
001 |
ANDA |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
Prescription |
No |
No |
AT |
2021/01/28
|
EPIC PHARMA LLC |