| ACETAMINOPHEN |
202605 |
001 |
ANDA |
ACETAMINOPHEN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
No
|
No
|
2016/06/13
|
2016/06/13
|
HIKMA |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
202935 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2016/06/15
|
2016/06/15
|
STRIDES PHARMA INTL |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
202935 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2016/06/15
|
2016/06/15
|
STRIDES PHARMA INTL |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
202935 |
004 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2016/06/15
|
2016/06/15
|
STRIDES PHARMA INTL |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
205001 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
No
|
2016/07/05
|
2016/07/05
|
STRIDES PHARMA INTL |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
205001 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
No
|
2016/07/05
|
2016/07/05
|
STRIDES PHARMA INTL |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
205001 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
2016/07/05
|
2016/07/05
|
STRIDES PHARMA INTL |
Discontinued |
| ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
207113 |
001 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
325MG; 7.5MG |
No
|
No
|
2016/09/27
(TA)
|
--
|
ACTAVIS LABS FL INC |
None (Tentative Approval) |
| ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE |
204209 |
001 |
ANDA |
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE |
TABLET;ORAL |
325MG;30MG;16MG |
No
|
No
|
2016/09/30
|
2016/09/30
|
PHARMOBEDIENT |
Discontinued |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
207118 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
No
|
No
|
2016/10/28
|
2016/10/28
|
NUVO PHARMS INC |
Prescription |
| ACETAMINOPHEN |
207229 |
001 |
ANDA |
ACETAMINOPHEN |
TABLET, EXTENDED RELEASE;ORAL |
650MG |
No
|
No
|
2016/11/09
|
2016/11/09
|
AUROBINDO PHARMA |
Over-the-counter |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206142 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
No
|
2016/11/14
|
2016/11/14
|
NOVEL LABS INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206142 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
No
|
2016/11/14
|
2016/11/14
|
NOVEL LABS INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206142 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
2016/11/14
|
2016/11/14
|
NOVEL LABS INC |
Discontinued |
| BUTALBITAL AND ACETAMINOPHEN |
207386 |
001 |
ANDA |
ACETAMINOPHEN; BUTALBITAL |
TABLET;ORAL |
300MG;50MG |
No
|
No
|
2016/11/15
|
2016/11/15
|
ANDA REPOSITORY |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207137 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
2016/11/29
|
2016/11/29
|
AMNEAL PHARMS |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206245 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2016/12/01
|
2016/12/01
|
NOVEL LABS INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206245 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2016/12/01
|
2016/12/01
|
NOVEL LABS INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206245 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2016/12/01
|
2016/12/01
|
NOVEL LABS INC |
Discontinued |
| OXYCODONE AND ACETAMINOPHEN |
207574 |
001 |
ANDA |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2016/12/13
|
2016/12/13
|
SANALUZ |
Discontinued |