APPLICATION
ANDA090121
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-23
LATEST ACTION
2026-07-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FINASTERIDEPrescription
FINASTERIDE 5MG · TABLET · ORAL
Approval history
2026-07-02Labeling · Supplement 17 · standardAP
2025-06-17Labeling · Supplement 16 · standardAP
2023-01-20Labeling · Supplement 13 · standardAP
2014-12-15Labeling · Supplement 7 · standardAP
2013-04-26Labeling · Supplement 6 · standardAP
2012-09-27Labeling · Supplement 5 · standardAP
2011-09-27Labeling · Supplement 4AP
2011-03-01Labeling · Supplement 2AP
2010-07-16Labeling · Supplement 1AP
2010-02-23OriginalAP
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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