APPLICATION
ANDA077214
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-23
LATEST ACTION
2022-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 5MG · TABLET · ORAL
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 10MG · TABLET · ORAL
Approval history
2022-11-17Labeling · Supplement 8 · standardAP
2015-06-01Labeling · Supplement 6 · standardAP
2013-09-18Labeling · Supplement 5 · standardAP
2010-08-16Labeling · Supplement 3AP
2008-09-03Labeling · Supplement 2AP
2008-05-29Labeling · Supplement 1AP
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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