Orange Book product · Brand (NDA)
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
At a glance
Apr 02, 1984
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 1984
42 yr 10 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15MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
AA
Application
NDA 011265
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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
- 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.
