APPLICATION
ANDA078179
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-13
LATEST ACTION
2019-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 12.5MG · TABLET, EXTENDED RELEASE · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 6.25MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2019-11-19Labeling · Supplement 15 · standardAP
2019-11-19Labeling · Supplement 16 · standardAP
2019-11-19Labeling · Supplement 14 · standardAP
2016-03-28Labeling · Supplement 12 · standardAP
2014-12-21Labeling · Supplement 9 · standardAP
2011-06-06OriginalAP
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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