APPLICATION
ANDA076437
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-28
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FINASTERIDEPrescription
FINASTERIDE 5MG · TABLET · ORAL
Approval history
2026-07-01Labeling · Supplement 12 · standardAP
2025-06-17Labeling · Supplement 10 · standardAP
2012-09-28Labeling · Supplement 8 · standardAP
2012-05-29Labeling · Supplement 6 · standardAP
2011-08-03Labeling · Supplement 5AP
2011-03-01Labeling · Supplement 4AP
2010-05-27Labeling · Supplement 3AP
2007-02-28OriginalAP
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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