APPLICATION
ANDA204229
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-11
LATEST ACTION
2020-07-02
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 1.75MG · TABLET · SUBLINGUAL
ZOLPIDEM TARTRATEPrescription
ZOLPIDEM TARTRATE 3.5MG · TABLET · SUBLINGUAL
Approval history
2020-07-02Labeling · Supplement 1 · standardAP
2020-07-02Labeling · Supplement 2 · standardAP
2017-09-11UNKNOWN · 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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