| DICLOFENAC SODIUM |
090066 |
001 |
ANDA |
DICLOFENAC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
25MG |
No
|
Yes
|
2010/12/01
|
2010/12/01
|
UNIQUE |
Prescription |
| DICLOFENAC SODIUM |
090066 |
002 |
ANDA |
DICLOFENAC SODIUM |
TABLET, DELAYED RELEASE;ORAL |
50MG |
No
|
Yes
|
2010/12/01
|
2010/12/01
|
UNIQUE |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
201089 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2012/07/09
|
2012/07/09
|
ACTAVIS LABS FL INC |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
201089 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2012/07/09
|
2012/07/09
|
ACTAVIS LABS FL INC |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
200158 |
001 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
50MG;0.2MG |
No
|
No
|
2013/05/09
|
2013/05/09
|
SANDOZ |
Prescription |
| DICLOFENAC SODIUM AND MISOPROSTOL |
200158 |
002 |
ANDA |
DICLOFENAC SODIUM; MISOPROSTOL |
TABLET, DELAYED RELEASE;ORAL |
75MG;0.2MG |
No
|
No
|
2013/05/09
|
2013/05/09
|
SANDOZ |
Prescription |
| DICLOFENAC SODIUM |
200936 |
001 |
ANDA |
DICLOFENAC SODIUM |
GEL;TOPICAL |
3% |
No
|
No
|
2013/10/28
|
2013/10/28
|
AMNEAL |
Prescription |
| 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 POTASSIUM |
204648 |
001 |
ANDA |
DICLOFENAC POTASSIUM |
CAPSULE;ORAL |
25MG |
No
|
No
|
2016/02/23
|
2016/02/23
|
BIONPHARMA |
Prescription |