| DICLOFENAC SODIUM |
207238 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
No
|
2017/11/02
(TA)
|
--
|
ACTAVIS LABS UT INC |
None (Tentative Approval) |
| DICLOFENAC SODIUM |
206411 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2018/04/17
|
2018/04/17
|
ZYDUS LIFESCIENCES |
Prescription |
| DICLOFENAC SODIUM |
210893 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
No
|
2018/07/27
|
2018/07/27
|
PADAGIS ISRAEL |
Prescription |
| DICLOFENAC SODIUM |
209903 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2018/08/03
|
2018/08/03
|
CIPLA |
Prescription |
| DICLOFENAC SODIUM |
209484 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2018/11/21
|
2018/11/21
|
HIKMA |
Discontinued |
| DICLOFENAC SODIUM |
204306 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2019/05/06
|
2019/05/06
|
AUROLIFE PHARMA LLC |
Over-the-counter |
| DICLOFENAC SODIUM |
211253 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2019/05/16
|
2019/05/16
|
PERRIGO PHARMA INTL |
Over-the-counter |
| DICLOFENAC SODIUM |
208786 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;INTRAVENOUS |
37.5MG/ML (37.5MG/ML) |
No
|
No
|
2019/06/18
|
2019/06/18
|
RISING |
Discontinued |
| DICLOFENAC SODIUM |
210986 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2020/01/27
|
2020/01/27
|
ENCUBE |
Over-the-counter |
| DICLOFENAC SODIUM AND MISOPROSTOL |
205143 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2020/02/19
|
2020/02/19
|
YUNG SHIN PHARM |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
205143 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2020/02/19
|
2020/02/19
|
YUNG SHIN PHARM |
Prescription |
| DICLOFENAC SODIUM |
206655 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2021/01/28
|
2021/01/28
|
EPIC PHARMA LLC |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
204355 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2021/07/15
|
2021/07/15
|
MICRO LABS |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
204355 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2021/07/15
|
2021/07/15
|
MICRO LABS |
Prescription |
| DICLOFENAC SODIUM |
207714 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
No
|
2022/05/06
|
2022/05/06
|
APOTEX |
Prescription |
| DICLOFENAC SODIUM |
212351 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
No
|
2022/07/27
|
2022/07/27
|
ALEMBIC |
Prescription |
| DICLOFENAC SODIUM |
208198 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
No
|
2022/08/18
|
2022/08/18
|
AMNEAL |
Prescription |
| DICLOFENAC SODIUM |
208021 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
Yes
|
2022/09/21
|
2022/09/20
|
LUPIN PHARMS |
Prescription |
| DICLOFENAC SODIUM |
216275 |
001 |
ANDA |
DICLOFENAC SODIUM |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
No
|
No
|
2022/09/23
|
2022/09/23
|
RICONPHARMA LLC |
Prescription |
| DICLOFENAC SODIUM |
208098 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
No
|
2022/09/29
|
2022/09/29
|
TARO |
Prescription |