APPLICATION
ANDA204170
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-24
LATEST ACTION
2023-03-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 6.25MG · TABLET, EXTENDED RELEASE · ORAL
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 12.5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-03-08Labeling · Supplement 9 · standardAP
2023-03-08Labeling · Supplement 7 · standardAP
2023-03-08Labeling · Supplement 1 · standardAP
2023-03-08Labeling · Supplement 15 · standardAP
2023-03-08Labeling · Supplement 6 · standardAP
2017-01-24UNKNOWN · 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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