APPLICATION
ANDA090789
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-03
LATEST ACTION
2025-04-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LETROZOLEDiscontinued
LETROZOLE 2.5MG · TABLET · ORAL
Approval history
2025-04-22Labeling · Supplement 4 · standardAP
2025-04-22Labeling · Supplement 5 · standardAP
2015-04-02Labeling · Supplement 1AP
2015-04-02Labeling · Supplement 3 · standardAP
2011-06-03OriginalAP
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.