APPLICATION
ANDA078561
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-16
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.25MG · TABLET, ORALLY DISINTEGRATING · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-01-17Labeling · Supplement 24 · standardAP
2023-01-05Labeling · Supplement 23 · standardAP
2021-02-05Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 15 · standardAP
2016-12-16Labeling · Supplement 14 · standardAP
2016-11-18Labeling · Supplement 13 · standardAP
2010-03-16OriginalAP
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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