APPLICATION
ANDA200266
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-10
LATEST ACTION
2022-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 6.25MG · TABLET, EXTENDED RELEASE · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 12.5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-11-14Labeling · Supplement 8 · standardAP
2019-11-15Labeling · Supplement 6 · standardAP
2019-11-15Labeling · Supplement 4 · standardAP
2019-11-15Labeling · Supplement 2 · standardAP
2019-11-15Labeling · Supplement 7 · standardAP
2019-11-15Labeling · Supplement 5 · standardAP
2019-11-15Labeling · Supplement 3 · standardAP
2015-03-19Labeling · Supplement 1 · standardAP
2013-09-10Not Applicable · 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.
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