APPLICATION
ANDA077914
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-28
LATEST ACTION
2014-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FINASTERIDEDiscontinued
FINASTERIDE 5MG · TABLET · ORAL
Approval history
2014-12-15Labeling · Supplement 9 · standardAP
2013-04-29Labeling · Supplement 8 · standardAP
2012-07-20Labeling · Supplement 5 · standardAP
2012-02-13Labeling · Supplement 3AP
2011-01-27Manufacturing (CMC) · Supplement 1AP
2010-12-22Labeling · Supplement 2AP
2007-03-28OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.