| DICLOFENAC SODIUM AND MISOPROSTOL |
200540 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2014/03/14
|
2014/03/14
|
EXELA HOLDINGS |
Discontinued |
| DICLOFENAC SODIUM AND MISOPROSTOL |
200540 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2014/03/14
|
2014/03/14
|
EXELA HOLDINGS |
Discontinued |
| DICLOFENAC SODIUM |
202027 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2014/05/27
|
2014/05/27
|
APOTEX |
Discontinued |
| DICLOFENAC SODIUM |
202393 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2014/11/24
|
2014/11/24
|
TWI PHARMS |
Discontinued |
| DICLOFENAC SODIUM |
202852 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2014/11/24
|
2014/11/24
|
WATSON LABS INC |
Prescription |
| DICLOFENAC SODIUM |
203818 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
Yes
|
2014/11/26
|
2014/11/26
|
TARO |
Prescription |
| DICLOFENAC SODIUM |
202769 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2015/07/08
|
2015/07/08
|
PAI HOLDINGS PHARM |
Discontinued |
| DICLOFENAC SODIUM |
204132 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2015/08/20
|
2015/08/20
|
LUPIN LTD |
Prescription |
| DICLOFENAC SODIUM |
208068 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
2% |
No
|
No
|
2015/10/14
(TA)
|
--
|
PADDOCK LABS |
None (Tentative Approval) |
| DICLOFENAC SODIUM |
203383 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION/DROPS;OPHTHALMIC |
0.1% |
No
|
No
|
2015/11/16
|
2015/11/16
|
ALTAIRE PHARMS INC |
Prescription |
| DICLOFENAC SODIUM |
206493 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
No
|
2015/12/02
|
2015/12/02
|
ACTAVIS MID ATLANTIC |
Prescription |
| DICLOFENAC SODIUM |
205878 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2015/12/09
|
2015/12/09
|
NOVEL LABS INC |
Prescription |
| 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 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 SODIUM |
206715 |
001 |
ANDA |
DICLOFENAC SODIUM |
SOLUTION;TOPICAL |
1.5% |
No
|
No
|
2017/08/07
|
2017/08/07
|
RISING |
Discontinued |