APPLICATION
ANDA074112
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-29
LATEST ACTION
2023-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.25MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET · ORAL
Approval history
2023-06-30Labeling · Supplement 38 · standardAP
2021-09-15Labeling · Supplement 36 · standardAP
2019-12-31Labeling · Supplement 31 · standardAP
2014-10-31Manufacturing (CMC) · Supplement 24AP
2012-11-29Labeling · Supplement 26AP
2008-02-26Labeling · Supplement 22AP
2002-12-09Manufacturing (CMC) · Supplement 16AP
2002-03-18Manufacturing (CMC) · Supplement 15AP
2002-03-18Manufacturing (CMC) · Supplement 14AP
2001-11-19Labeling · Supplement 13AP
2001-10-01Manufacturing (CMC) · Supplement 12AP
2001-02-16Labeling · Supplement 11AP
1999-09-13Manufacturing (CMC) · Supplement 9AP
1999-03-01Manufacturing (CMC) · Supplement 8AP
1999-03-01Manufacturing (CMC) · Supplement 7AP
1998-09-08Manufacturing (CMC) · Supplement 5AP
1998-07-27Manufacturing (CMC) · Supplement 6AP
1998-06-09Labeling · Supplement 4AP
1998-06-09Manufacturing (CMC) · Supplement 3AP
1997-11-25Manufacturing (CMC) · Supplement 2AP
1997-08-29Labeling · Supplement 1AP
1995-12-29OriginalAP
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.