← FDA DRUG APPROVALS

FDA ANDA · ANDA078190

LETROZOLE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA078190
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-24
LATEST ACTION
2026-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LETROZOLEDiscontinued
LETROZOLE 2.5MG · TABLET · ORAL

Approval history

2026-03-03Labeling · Supplement 10 · standardAP
2026-03-03Labeling · Supplement 5 · standardAP
2011-03-08Labeling · Supplement 2AP
2008-12-24OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →