APPLICATION
ANDA203346
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-31
LATEST ACTION
2023-08-29
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
2023-08-29Labeling · Supplement 4 · standardAP
2023-08-29Labeling · Supplement 7 · standardAP
2023-08-29Labeling · Supplement 5 · standardAP
2019-12-31Labeling · Supplement 2 · standardAP
2015-07-31UNKNOWN · OriginalAP
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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