APPLICATION
ANDA078056
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-13
LATEST ACTION
2023-06-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2023-06-23Labeling · Supplement 18 · standardAP
2023-06-23Labeling · Supplement 20 · standardAP
2023-06-23Labeling · Supplement 21 · standardAP
2011-11-22Labeling · Supplement 11AP
2007-02-13OriginalAP
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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