APPLICATION
ANDA090061
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-07
LATEST ACTION
2022-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FINASTERIDEPrescription
FINASTERIDE 5MG · TABLET · ORAL
Approval history
2022-03-11Labeling · Supplement 17 · standardAP
2022-03-11Labeling · Supplement 18 · standardAP
2015-04-06Manufacturing (CMC) · Supplement 9 · unknownAP
2015-04-06Labeling · Supplement 8 · standardAP
2015-03-19Manufacturing (CMC) · Supplement 10 · unknownAP
2013-04-26Labeling · Supplement 6 · standardAP
2013-02-22Labeling · Supplement 5 · standardAP
2012-02-14Labeling · Supplement 3AP
2010-12-22Labeling · Supplement 1AP
2010-06-07OriginalAP
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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