APPLICATION
ANDA077322
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2022-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL
Approval history
2022-09-28Labeling · Supplement 20 · standardAP
2019-11-19Labeling · Supplement 17 · standardAP
2019-11-19Labeling · Supplement 15 · standardAP
2019-11-19Labeling · Supplement 18 · standardAP
2019-11-19Labeling · Supplement 16 · standardAP
2015-03-19Labeling · Supplement 14 · standardAP
2013-09-04Labeling · Supplement 12 · standardAP
2010-11-30Labeling · Supplement 9AP
2009-03-10Labeling · Supplement 6AP
2008-05-23Labeling · Supplement 2AP
2008-05-13Labeling · Supplement 5AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.