APPLICATION
ANDA078341
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-30
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 31 · standardAP
2022-05-18Labeling · Supplement 24 · standardAP
2022-05-18Labeling · Supplement 17 · standardAP
2022-05-18Labeling · Supplement 23 · standardAP
2022-05-18Labeling · Supplement 21 · standardAP
2015-12-23Labeling · Supplement 15 · standardAP
2014-12-14Labeling · Supplement 12 · standardAP
2013-02-26Labeling · Supplement 10 · standardAP
2012-05-23Labeling · Supplement 8 · standardAP
2011-09-27Labeling · Supplement 7AP
2010-06-10Labeling · Supplement 5AP
2009-03-19Labeling · Supplement 3AP
2007-10-30OriginalAP
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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