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FDA ANDA · ANDA202940

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

Sponsor: PHARM ASSOC

APPLICATION
ANDA202940
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-21
LATEST ACTION
2023-05-08
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPrescription
BROMPHENIRAMINE MALEATE 2MG/5ML, DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 30MG/5ML · SYRUP · ORAL

Approval history

2023-05-08Labeling · Supplement 4 · standardAP
2014-07-21UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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