APPLICATION
ANDA200739
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-15
LATEST ACTION
2023-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.25MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET · ORAL
Approval history
2023-10-18Labeling · Supplement 2 · standardAP
2015-04-15Not Applicable · 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.
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.