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FDA ANDA · ANDA077777

ALPRAZOLAM

Sponsor: SANDOZ INC

APPLICATION
ANDA077777
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-30
LATEST ACTION
2023-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ALPRAZOLAMDiscontinued
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-06-30Labeling · Supplement 7 · standardAP
2023-06-30Labeling · Supplement 6 · standardAP
2011-11-22Labeling · Supplement 4AP
2006-06-30OriginalAP
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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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