| OXTELLAR XR |
202810 |
001 |
NDA |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
Yes
|
No
|
2012/10/19
|
2012/10/19
|
SUPERNUS PHARMS |
Prescription |
| OXTELLAR XR |
202810 |
002 |
NDA |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Yes
|
No
|
2012/10/19
|
2012/10/19
|
SUPERNUS PHARMS |
Prescription |
| OXTELLAR XR |
202810 |
003 |
NDA |
OXCARBAZEPINE |
TABLET, EXTENDED RELEASE;ORAL |
600MG |
Yes
|
Yes
|
2012/10/19
|
2012/10/19
|
SUPERNUS PHARMS |
Prescription |
| PIRMELLA 7/7/7 |
201510 |
001 |
ANDA |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG |
No
|
No
|
2013/04/24
|
2013/04/24
|
LUPIN LTD |
Discontinued |
| PIRMELLA 1/35 |
201512 |
001 |
ANDA |
ETHINYL ESTRADIOL; NORETHINDRONE |
TABLET;ORAL-28 |
0.035MG;1MG |
No
|
No
|
2013/04/24
|
2013/04/24
|
LUPIN LTD |
Discontinued |
| KYBELLA |
206333 |
001 |
NDA |
DEOXYCHOLIC ACID |
SOLUTION;SUBCUTANEOUS |
20MG/2ML (10MG/ML) |
Yes
|
Yes
|
2015/04/29
|
2015/04/29
|
ABBVIE |
Prescription |