APPLICATION
ANDA078387
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-30
LATEST ACTION
2024-03-15
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
2024-03-15Labeling · Supplement 9 · standardAP
2024-03-15Labeling · Supplement 5 · standardAP
2024-03-15Labeling · Supplement 10 · standardAP
2024-03-15Labeling · Supplement 6 · standardAP
2008-05-30OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.