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FDA ANDA · ANDA078648

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE

Sponsor: AVANTHI INC

APPLICATION
ANDA078648
TYPE
ANDA
ORIGINAL APPROVAL
2013-02-27
LATEST ACTION
2013-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATEDiscontinued
DEXBROMPHENIRAMINE MALEATE 6MG, PSEUDOEPHEDRINE SULFATE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2013-02-27Original — Label ↗AP
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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