APPLICATION
ANDA074215
TYPE
ANDA
ORIGINAL APPROVAL
1994-01-27
LATEST ACTION
2025-07-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALPRAZOLAMDiscontinued
ALPRAZOLAM 2MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.25MG · TABLET · ORAL
Approval history
2025-07-03Labeling · Supplement 27 · standardAP
2019-12-31Labeling · Supplement 24 · standardAP
2012-06-01Manufacturing (CMC) · Supplement 19AP
2011-09-27Labeling · Supplement 20AP
2008-06-28Labeling · Supplement 18AP
2002-04-03Labeling · Supplement 6AP
2000-10-18Labeling · Supplement 5AP
1998-05-06Manufacturing (CMC) · Supplement 4AP
1998-02-05Manufacturing (CMC) · Supplement 2AP
1998-02-03Manufacturing (CMC) · Supplement 3AP
1997-11-07Labeling · Supplement 1AP
1994-01-27OriginalAP
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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