APPLICATION
ANDA078970
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-11
LATEST ACTION
2022-09-02
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
2022-09-02Labeling · Supplement 16 · standardAP
2019-11-29Manufacturing (CMC) · Supplement 11 · unknownAP
2019-11-29Labeling · Supplement 9 · standardAP
2019-11-29Labeling · Supplement 7 · standardAP
2019-11-29Labeling · Supplement 5 · standardAP
2019-11-29Labeling · Supplement 12 · standardAP
2019-11-29Labeling · Supplement 10 · standardAP
2019-11-29Labeling · Supplement 6 · standardAP
2015-11-05Labeling · Supplement 3 · standardAP
2015-03-19Labeling · Supplement 2 · standardAP
2013-09-11OriginalAP
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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