APPLICATION
ANDA078449
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-12
LATEST ACTION
2023-10-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ALPRAZOLAMDiscontinued
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMDiscontinued
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-10-23Labeling · Supplement 6 · standardAP
2023-10-23Labeling · Supplement 4 · standardAP
2023-10-23Labeling · Supplement 5 · standardAP
2015-12-23Labeling · Supplement 2AP
2015-12-23Manufacturing (CMC) · Supplement 1AP
2013-01-28Labeling · Supplement 3 · standardAP
2008-11-12OriginalAP
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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