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FDA ANDA · ANDA078483

ZOLPIDEM TARTRATE

Sponsor: SYNTHON PHARMS

APPLICATION
ANDA078483
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-12
LATEST ACTION
2011-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 12.5MG · TABLET, EXTENDED RELEASE · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 6.25MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2011-06-06OriginalAP
2011-04-12OriginalAP
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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