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Active ingredient

Leflunomide

40 finished FDA listings contain Leflunomide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
LEFLUNOMIDE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
17
Strengths listed
10 mg/1 · 100 mg/1 · 20 mg/1
Brand names in FDA listings
Arava

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 27169

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 020905SANOFI AVENTIS US1998-09-103
ANDA 077086HERITAGE2005-09-138
ANDA 077090APOTEX2005-09-136
ANDA 091369ALEMBIC PHARMS LTD2011-11-214
ANDA 212308ZYDUS LIFESCIENCES2019-04-247
ANDA 212453ABHAI LLC2019-06-032
ANDA 211863LUPIN2020-02-043
ANDA 213652AUROBINDO PHARMA2021-03-295
ANDA 213497AET PHARMA2021-05-102

Official labeling on DailyMed

Showing the 12 most recent of 25 labels.

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