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 |
Prescription |
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
|
APOZEAL PHARMS |
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
|
No
|
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
|
No
|
2017/03/31
|
2017/03/31
|
SPECGX LLC |
Prescription |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206718 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
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) |
HYDROCODONE BITARTRATE |
206952 |
005 |
ANDA |
HYDROCODONE BITARTRATE |
CAPSULE, EXTENDED RELEASE;ORAL |
40MG |
No
|
No
|
2017/04/05
(TA)
|
--
|
ACTAVIS LABS FL INC |
None (Tentative Approval) |
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
206660 |
001 |
ANDA |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SOLUTION;ORAL |
4MG/5ML;5MG/5ML;60MG/5ML |
No
|
No
|
2017/05/15
|
2017/05/15
|
APOZEAL PHARMS |
Discontinued |
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE |
206891 |
001 |
ANDA |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
SOLUTION;ORAL |
4MG/5ML;5MG/5ML |
No
|
No
|
2017/06/09
|
2017/06/09
|
ACELLA |
Discontinued |