APPLICATION
ANDA090934
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-03
LATEST ACTION
2025-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LETROZOLEPrescription
LETROZOLE 2.5MG · TABLET · ORAL
Approval history
2025-10-01Labeling · Supplement 17 · standardAP
2025-10-01Labeling · Supplement 18 · standardAP
2021-04-02Labeling · Supplement 11 · standardAP
2021-04-02Labeling · Supplement 14 · standardAP
2015-02-13Labeling · Supplement 5 · standardAP
2015-02-13Labeling · Supplement 6 · standardAP
2014-07-19Manufacturing (CMC) · Supplement 1AP
2012-05-15Manufacturing (CMC) · Supplement 2AP
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.