Orange Book product · Generic (ANDA)
PROMETHAZINE W/ DEXTROMETHORPHAN
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Jan 04, 1985
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 04, 1985
42 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Strength
15MG/5ML;6.25MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 088864
Product number
001
Marketing status
RX
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
- 1984PROMETH W/ DEXTROMETHORPHANGeneric (ANDA)
ANDA 088762 · G AND W LABS INC
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.
