← FDA DRUG APPROVALS

FDA ANDA · ANDA077903

ZOLPIDEM TARTRATE

Sponsor: TORRENT PHARMS

APPLICATION
ANDA077903
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-17
LATEST ACTION
2025-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-01-14Labeling · Supplement 34 · standardAP
2022-09-12Labeling · Supplement 30 · standardAP
2019-11-29Labeling · Supplement 29 · standardAP
2019-11-29Labeling · Supplement 27 · standardAP
2019-11-29Labeling · Supplement 25 · standardAP
2019-11-29Labeling · Supplement 23 · standardAP
2019-11-29Labeling · Supplement 28 · standardAP
2019-11-29Labeling · Supplement 24 · standardAP
2014-12-24Labeling · Supplement 19 · standardAP
2014-12-24Labeling · Supplement 17 · standardAP
2010-08-16Labeling · Supplement 11AP
2010-03-10Manufacturing (CMC) · Supplement 6AP
2010-03-10Manufacturing (CMC) · Supplement 9AP
2010-03-10Manufacturing (CMC) · Supplement 7AP
2010-01-08Labeling · Supplement 4AP
2007-08-17Original — Other Important Information from FDA ↗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.

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 →