| DICLOFENAC SODIUM |
208077 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
1% |
No
|
No
|
2016/03/18
|
2016/03/18
|
AMNEAL PHARMS |
Over-the-counter |
| DICLOFENAC SODIUM |
206298 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
Yes
|
2016/04/28
|
2016/04/28
|
TARO |
Prescription |
| DICLOFENAC POTASSIUM |
202964 |
001 |
ANDA |
DICLOFENAC POTASSIUM |
FOR SOLUTION;ORAL |
50MG |
No
|
No
|
2016/05/02
|
2016/05/02
|
PAR FORM |
Prescription |
| DICLOFENAC SODIUM |
206116 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2016/09/02
|
2016/09/02
|
AMNEAL PHARMS |
Prescription |
| DICLOFENAC SODIUM |
208301 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
No
|
2016/09/13
|
2016/09/13
|
GLENMARK PHARMS LTD |
Prescription |
| DICLOFENAC SODIUM |
203786 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% W/W |
No
|
No
|
2016/10/28
(TA)
|
--
|
VERSAPHARM INC |
None (Tentative Approval) |
| DICLOFENAC SODIUM AND MISOPROSTOL |
203995 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2016/11/25
|
2016/11/25
|
AMNEAL PHARMS |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
203995 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2016/11/25
|
2016/11/25
|
AMNEAL PHARMS |
Prescription |
| DICLOFENAC |
207393 |
001 |
ANDA |
DICLOFENAC |
CAPSULE;ORAL |
18MG |
No
|
No
|
2016/12/02
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| DICLOFENAC |
207393 |
002 |
ANDA |
DICLOFENAC |
CAPSULE;ORAL |
35MG |
No
|
No
|
2016/12/02
(TA)
|
--
|
LUPIN LTD |
None (Tentative Approval) |
| DICLOFENAC SODIUM |
206715 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2017/08/07
|
2017/08/07
|
RISING |
Discontinued |
| 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 POTASSIUM |
210078 |
001 |
ANDA |
DICLOFENAC POTASSIUM |
CAPSULE;ORAL |
25MG |
No
|
No
|
2019/12/03
|
2019/12/03
|
STRIDES PHARMA |
Prescription |