← FDA DRUG APPROVALS

FDA ANDA · ANDA076578

ZOLPIDEM TARTRATE

Sponsor: RISING

APPLICATION
ANDA076578
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2022-11-21
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

2022-11-21Labeling · Supplement 21 · standardAP
2019-10-25Labeling · Supplement 18 · standardAP
2019-10-25Labeling · Supplement 14 · standardAP
2019-10-25Labeling · Supplement 19 · standardAP
2019-10-25Labeling · Supplement 17 · standardAP
2019-10-25Labeling · Supplement 15 · standardAP
2019-10-25Labeling · Supplement 13 · standardAP
2015-03-19Labeling · Supplement 12 · standardAP
2014-03-31Labeling · Supplement 11 · standardAP
2011-01-21Labeling · Supplement 8AP
2008-11-19Labeling · Supplement 4AP
2007-04-23Original — 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 →