APPLICATION
ANDA202657
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-08
LATEST ACTION
2024-12-06
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 5MG · TABLET · SUBLINGUAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 10MG · TABLET · SUBLINGUAL
Approval history
2024-12-06Labeling · Supplement 2 · standardAP
2016-08-08UNKNOWN · OriginalAP
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.