Quick answers
- What is Arava?
- Arava is a brand name of Leflunomide, a prescription medicine. The FDA NDC Directory lists 3 Arava products in 3 strengths and forms.
- Who makes Arava?
- Sanofi Aventis US holds the FDA application for Arava (NDA020905, approved September 10, 1998).
- Is there a generic or store brand of Arava?
- Yes. The FDA NDC Directory lists 17 other products with the same active ingredients, strength and form as a Arava product, 17 of them generic. Ask your pharmacist whether one is right for you.
- Has Arava been recalled?
- No recall linked to Arava products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Arava is
Each Arava product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Leflunomide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| leflunomide 10 mg tablet, film coated (oral) | Arava | 7 products, 7 companies | DailyMed |
| leflunomide 100 mg tablet, film coated (oral) | Arava | None listed | DailyMed |
| leflunomide 20 mg tablet, film coated (oral) | Arava | 10 products, 8 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Leflunomide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020905 | Sanofi Aventis US | September 10, 1998 | 3 |
Companies that list Arava
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Arava products.
- sanofi-aventis U.S. LLC3 products
Recalls
No recall linked to Arava products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.