| DULOXETINE HYDROCHLORIDE |
090775 |
001 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
20MG |
No
|
No
|
2011/02/02
(TA)
|
--
|
SANDOZ |
None (Tentative Approval) |
| DULOXETINE HYDROCHLORIDE |
090775 |
002 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
30MG |
No
|
No
|
2011/02/02
(TA)
|
--
|
SANDOZ |
None (Tentative Approval) |
| DULOXETINE HYDROCHLORIDE |
090775 |
003 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
60MG |
No
|
No
|
2011/02/02
(TA)
|
--
|
SANDOZ |
None (Tentative Approval) |
| NULOJIX |
125288 |
001 |
BLA |
BELATACEPT |
INJECTABLE; INJECTION |
250MG |
No
|
No
|
2011/06/15
|
--
|
BRISTOL MYERS SQUIBB |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090773 |
001 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
20MG |
No
|
No
|
2011/07/06
(TA)
|
--
|
WOCKHARDT |
None (Tentative Approval) |
| DULOXETINE HYDROCHLORIDE |
090773 |
002 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
30MG |
No
|
No
|
2011/07/06
(TA)
|
--
|
WOCKHARDT |
None (Tentative Approval) |
| DULOXETINE HYDROCHLORIDE |
090773 |
003 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED RELEASE; ORAL |
60MG |
No
|
No
|
2011/07/06
(TA)
|
--
|
WOCKHARDT |
None (Tentative Approval) |
| LACTULOSE |
090502 |
001 |
ANDA |
LACTULOSE |
SOLUTION;ORAL, RECTAL |
10GM/15ML |
No
|
Yes
|
2012/01/25
|
2012/01/25
|
FRESENIUS KABI |
Prescription |
| LACTULOSE |
090503 |
001 |
ANDA |
LACTULOSE |
SOLUTION;ORAL |
10GM/15ML |
No
|
No
|
2012/01/25
|
2012/01/25
|
FRESENIUS KABI |
Prescription |
| TAMSULOSIN HYDROCHLORIDE |
202010 |
001 |
ANDA |
TAMSULOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
0.4MG |
No
|
No
|
2013/01/04
|
2013/01/04
|
PH HEALTH |
Discontinued |
| TAMSULOSIN HYDROCHLORIDE |
202433 |
001 |
ANDA |
TAMSULOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
0.4MG |
No
|
No
|
2013/04/30
|
2013/04/30
|
AUROBINDO PHARMA LTD |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090694 |
001 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
LUPIN LTD |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090694 |
002 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 30MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
LUPIN LTD |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090694 |
003 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 40MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
LUPIN LTD |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090694 |
004 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 60MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
LUPIN LTD |
Prescription |
| DULOXETINE HYDROCHLORIDE |
090723 |
001 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
GRAVITI PHARMS |
Discontinued |
| DULOXETINE HYDROCHLORIDE |
090723 |
002 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 30MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
GRAVITI PHARMS |
Discontinued |
| DULOXETINE HYDROCHLORIDE |
090723 |
003 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 60MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
GRAVITI PHARMS |
Discontinued |
| DULOXETINE HYDROCHLORIDE |
090745 |
001 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 20MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
SUN PHARM |
Discontinued |
| DULOXETINE HYDROCHLORIDE |
090745 |
002 |
ANDA |
DULOXETINE HYDROCHLORIDE |
CAPSULE, DELAYED REL PELLETS;ORAL |
EQ 30MG BASE |
No
|
No
|
2013/12/11
|
2013/12/11
|
SUN PHARM |
Discontinued |