| 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 |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207171 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
No
|
2017/06/20
|
2017/06/20
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207171 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
No
|
2017/06/20
|
2017/06/20
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207171 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
2017/06/20
|
2017/06/20
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209036 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209036 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209036 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209037 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209037 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
209037 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2017/06/21
|
2017/06/21
|
ABHAI LLC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207172 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2017/06/22
|
2017/06/22
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207172 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2017/06/22
|
2017/06/22
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
207172 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2017/06/22
|
2017/06/22
|
LANNETT CO INC |
Discontinued |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
206869 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
No
|
No
|
2017/06/23
|
2017/06/23
|
AMNEAL PHARMS NY |
Prescription |
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE |
207176 |
001 |
ANDA |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
TABLET;ORAL |
1.5MG;5MG |
No
|
Yes
|
2017/08/07
|
2017/08/07
|
AVANTHI INC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
210211 |
001 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
No
|
No
|
2017/10/30
|
2017/10/30
|
WES PHARMA INC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
210211 |
002 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
No
|
No
|
2017/10/30
|
2017/10/30
|
WES PHARMA INC |
Prescription |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
210211 |
003 |
ANDA |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
No
|
No
|
2017/10/30
|
2017/10/30
|
WES PHARMA INC |
Prescription |