Orange Book product · Generic (ANDA)
PROMETH W/ DEXTROMETHORPHAN
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Oct 31, 1984
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 1984
42 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Strength
15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 088762
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- 1984PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEBrand (NDA)
NDA 011265 · ANI PHARMS
- 2026PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 218264 · HETERO LABS LTD III
- 2012PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 091687 · COSETTE PHARMS NC
- 2011PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 090575 · AMNEAL PHARMS
- 2006PROMETHAZINE DMGeneric (ANDA)
ANDA 040649 · PAI HOLDINGS
- 1996PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 040027 · HIKMA
- 1987PHERAZINE DMGeneric (ANDA)
ANDA 088913 · HALSEY
- 1985PROMETHAZINE W/ DEXTROMETHORPHANGeneric (ANDA)
ANDA 088864 · PHARMOBEDIENT
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
