APPLICATION
ANDA201509
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-01
LATEST ACTION
2019-11-15
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 10MG · TABLET · SUBLINGUAL
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 5MG · TABLET · SUBLINGUAL
Approval history
2019-11-15Labeling · Supplement 1 · standardAP
2019-11-15Labeling · Supplement 2 · standardAP
2016-08-01Not 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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