APPLICATION
ANDA074174
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-19
LATEST ACTION
2023-05-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALPRAZOLAMPrescription
ALPRAZOLAM 2MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.5MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 1MG · TABLET · ORAL
ALPRAZOLAMPrescription
ALPRAZOLAM 0.25MG · TABLET · ORAL
Approval history
2023-05-02Labeling · Supplement 15 · standardAP
2021-09-20Labeling · Supplement 11 · standardAP
2019-12-31Labeling · Supplement 7 · standardAP
2007-03-08Labeling · Supplement 4AP
1999-04-30Manufacturing (CMC) · Supplement 2AP
1997-03-27Labeling · Supplement 1AP
1993-10-19OriginalAP
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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