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FDA ANDA · ANDA202993

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Sponsor: PAR PHARM INC

APPLICATION
ANDA202993
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval)

Products

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATENone (Tentative Approval)
DEXTROMETHORPHAN HYDROBROMIDE 20MG, QUINIDINE SULFATE 10MG · CAPSULE · ORAL

Approval history

2015-12-23UNKNOWN · OriginalTA
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.

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