Orange Book product · Generic (ANDA)
BROMANATE DM
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
At a glance
Mar 07, 1985
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 07, 1985
41 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Strength
2MG/5ML;10MG/5ML;30MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 088722
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- 1984DIMETANE-DXBrand (NDA)
NDA 019279 · ROBINS AH
- 2020BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 202955 · RHODES PHARMS
- 2020BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 203997 · BIONPHARMA
- 2020BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 210647 · ALKEM LABS LTD
- 2020BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 211170 · HIBROW HLTHCARE
- 2020BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 213125 · CHARTWELL MOLECULAR
- 2018BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 207676 · DR REDDYS LABS SA
- 2017BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 205112 · TARO
- 2016BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 203375 · ACELLA
- 2014BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 202940 · PHARM ASSOC
- 2014BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEGeneric (ANDA)
ANDA 205292 · PADAGIS US
- 1988BROMFED-DMGeneric (ANDA)
ANDA 089681 · WOCKHARDT
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.
