APPLICATION
ANDA077359
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2020-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
ZOLPIDEM TARTRATEDiscontinued
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL
Approval history
2020-11-24Labeling · Supplement 10 · standardAP
2020-11-24Labeling · Supplement 9 · standardAP
2008-10-14Labeling · Supplement 2AP
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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