APPLICATION
ANDA090871
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-07
LATEST ACTION
2024-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-04-11Labeling · Supplement 11 · standardAP
2024-04-11Labeling · Supplement 8 · standardAP
2024-04-11Labeling · Supplement 12 · standardAP
2024-04-11Labeling · Supplement 10 · standardAP
2013-09-19Labeling · Supplement 6 · standardAP
2011-08-22Labeling · Supplement 1AP
2011-06-07OriginalAP
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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