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Active ingredient

Letrozole

24 finished FDA listings contain Letrozole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LETROZOLE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
20
Strengths listed
2.5 mg/1
Brand names in FDA listings
Femara, Letrozole

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72965

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020726NOVARTIS PHARMS1997-07-251
ANDA 200161NATCO PHARMA LTD2011-06-035
ANDA 090934ACCORD HLTHCARE2011-06-036
ANDA 091191PHARMOBEDIENT2011-06-032
ANDA 090289TEVA PHARMS2011-06-033
ANDA 205869BEIJING YILING2018-11-146
ANDA 211717EUGIA PHARMA2019-01-111

Official labeling on DailyMed

Showing the 12 most recent of 24 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.