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FDA ANDA · ANDA074456

ALPRAZOLAM

Sponsor: WATSON LABS

APPLICATION
ANDA074456
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-31
LATEST ACTION
1998-03-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.25MG · TABLET · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET · ORAL

Approval history

1998-03-17Manufacturing (CMC) · Supplement 2AP
1998-03-17Manufacturing (CMC) · Supplement 3AP
1997-03-27Labeling · Supplement 1AP
1995-08-31OriginalAP
VIEW ON DRUGS@FDA ↗

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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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