← FDA DRUG APPROVALS

FDA ANDA · ANDA203375

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE

brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide

Sponsor: ACELLA

APPLICATION
ANDA203375
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-20
LATEST ACTION
2022-10-27
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

2022-10-27Labeling · Supplement 5 · standardAP
2016-09-20UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →