APPLICATION
ANDA202716
TYPE
ANDA
ORIGINAL APPROVAL
2013-05-16
LATEST ACTION
2019-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LETROZOLEDiscontinued
LETROZOLE 2.5MG · TABLET · ORAL
Approval history
2019-05-19Labeling · Supplement 2 · standardAP
2019-05-19Labeling · Supplement 3 · standardAP
2015-09-21Manufacturing (CMC) · Supplement 1 · unknownAP
2013-05-16UNKNOWN · OriginalAP
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.