NDC 0088-2162

Arava 100 mg tablet, film coated

On the label: sanofi-aventis U.S. LLC.

France: 1Germany: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Opella Healthcare International SasCompiegne, FranceMakes it, tests it, packages it and labels it Problems found, fixed voluntarilyJan 10, 2025 · 6 inspections
Sanofi-Aventis Deutschland GmbHFrankfurt am Main, GermanyMakes the active ingredient Problems found, fixed voluntarilyMar 25, 2022 · 10 inspections, 1 with FDA action

Product details

Generic drug
Leflunomide: every company that makes it
Form
tablet, film coated, oral
Strength
100 mg
Approval
NDA NDA020905
On the market since
Sep 10, 1998
Package NDCs
0088-2162-33
Official label
DailyMed (National Library of Medicine), updated Jun 4, 2025

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