← FDA DRUG APPROVALS

FDA ANDA · ANDA078426

ZOLPIDEM TARTRATE

Sponsor: WOCKHARDT

APPLICATION
ANDA078426
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-15
LATEST ACTION
2014-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL

Approval history

2014-11-26Labeling · Supplement 6 · standardAP
2008-01-16Labeling · Supplement 2AP
2007-05-15OriginalOther Important Information from FDAAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →