← FDA DRUG APPROVALS

FDA ANDA · ANDA207676

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA207676
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-04
LATEST ACTION
2018-12-04
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

2018-12-04UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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