| 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 |
| 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 |
| 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 |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
203535 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/02/13
|
2017/02/13
|
NOVEL LABS INC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
205731 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/02/15
|
2017/02/15
|
PADAGIS US |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
207487 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
Yes
|
2017/02/21
|
2017/02/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE |
204765 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
SYRUP;ORAL |
1.5MG/5ML;5MG/5ML |
No
|
No
|
2017/03/06
|
2017/03/06
|
SCIEGEN PHARMS INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206484 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2017/03/24
|
2017/03/24
|
UPSHER SMITH LABS |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206484 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2017/03/24
|
2017/03/24
|
UPSHER SMITH LABS |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206484 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2017/03/24
|
2017/03/24
|
UPSHER SMITH LABS |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206718 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
Yes
|
2017/03/31
|
2017/03/31
|
SPECGX LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206718 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
Yes
|
2017/03/31
|
2017/03/31
|
SPECGX LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206718 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
Yes
|
2017/03/31
|
2017/03/31
|
SPECGX LLC |
Prescription |
| HYDROCODONE BITARTRATE |
206952 |
001 |
ANDA |
HYDROCODONE BITARTRATE |
CAPSULE, EXTENDED RELEASE; ORAL |
10MG |
No
|
No
|
2017/04/05
(TA)
|
--
|
ACTAVIS LABS FL INC |
None (Tentative Approval) |