APPLICATION
ANDA074085
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-16
LATEST ACTION
1998-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.25MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 2MG · TABLET · ORAL
Approval history
1998-02-10Manufacturing (CMC) · Supplement 7AP
1997-03-06Labeling · Supplement 6AP
1996-02-26Manufacturing (CMC) · Supplement 1AP
1996-02-26Labeling · Supplement 2AP
1996-01-23Manufacturing (CMC) · Supplement 3AP
1996-01-23Labeling · Supplement 4AP
1994-02-16OriginalAP
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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