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Data / Drug companies / Leflunomide

Leflunomide: 19 companies and 40 products in the FDA NDC directory

Leflunomide is listed in the FDA National Drug Code Directory by 19 companies, with 40 products in commercial distribution. 37 of the products (92.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on January 3, 2022.

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Companies listing it
19
Products
40
Generic (ANDA) products
37 (92.5%)
Application numbers
9
Routes
Oral
Brand names
Arava
openFDA record search
api.fda.gov

Companies that list leflunomide

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack4tablet, film coated; tabletGeneric drugs (ANDA)March 29, 2021
Sanofi-Aventis U.S. LLC3tablet, film coatedNew drug applications (NDA)September 10, 1998
A-S Medication Solutions2tablet, film coatedGeneric drugs (ANDA)March 29, 2021
Alembic Pharmaceuticals Inc.2tabletGeneric drugs (ANDA)December 1, 2016
Alembic Pharmaceuticals Limited2tabletGeneric drugs (ANDA)December 1, 2016
Apotex Corp.2tabletGeneric drugs (ANDA)September 13, 2005
Aurobindo Pharma Limited2tablet, film coatedGeneric drugs (ANDA)March 29, 2021
AvKARE2tabletGeneric drugs (ANDA)June 13, 2019
AvPAK2tabletGeneric drugs (ANDA)September 17, 2020
Bryant Ranch Prepack2tabletGeneric drugs (ANDA)October 29, 2009
Burel Pharmaceuticals, LLC2tablet, film coatedGeneric drugs (ANDA)January 3, 2022
Chartwell RX, LLC2tabletGeneric drugs (ANDA)October 29, 2009
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.2tabletGeneric drugs (ANDA)October 29, 2009
KVK-Tech, Inc.2tabletGeneric drugs (ANDA)July 23, 2020
Lupin Pharmaceuticals, Inc.2tablet, film coatedGeneric drugs (ANDA)August 31, 2020
NuCare Pharmaceuticals,Inc.2tablet, film coatedGeneric drugs (ANDA)August 31, 2020
Zydus Lifesciences Limited2tablet, film coatedGeneric drugs (ANDA)April 26, 2019
Zydus Pharmaceuticals USA Inc.2tablet, film coatedGeneric drugs (ANDA)April 26, 2019
Bryant Ranch Prepack1tablet, film coatedGeneric drugs (ANDA)March 29, 2021

Dosage forms

Dosage formProductsShare
Tablet, film coated2050%
Tablet2050%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)3792.5%
New drug applications (NDA)37.5%

Pharmacologic classes

ClassProducts
Antirheumatic Agent40

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.