| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
011265 |
002 |
NDA |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Yes
|
No
|
1957/12/03
|
1984/04/02
|
ANI PHARMS |
Discontinued |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
040027 |
001 |
ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
No
|
No
|
1996/07/31
|
1996/07/31
|
HIKMA |
Discontinued |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
090575 |
001 |
ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
No
|
No
|
2011/02/08
|
2011/02/08
|
AMNEAL PHARMS |
Prescription |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE |
091687 |
001 |
ANDA |
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
15MG/5ML;6.25MG/5ML |
No
|
No
|
2012/06/28
|
2012/06/28
|
TRIS PHARMA INC |
Prescription |