Leflunomide

Treats active rheumatoid arthritis (RA). ANDA 77086, held by Heritage. Leflunomide.

As of Nov 14, 2026, ANDA 77086 (Leflunomide), held by Heritage, was first approved by FDA on Sep 13, 2005, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 13, 2005
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Leflunomide Tablets, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 13, 2005	Original application	Approved	Letter

Products

2 strengths and forms


Leflunomide10MG · tablet;oral	Leflunomide	Rx
Leflunomide20MG · tablet;oral	Leflunomide	Rx

All 8 submissions, including labeling and manufacturing supplements


Oct 24, 2025	Supplement 35Labeling · Standard review	Approved	None posted
Apr 18, 2017	Supplement 17Labeling · Standard review	Approved	None posted
Feb 15, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Aug 30, 2011	Supplement 10Labeling	Approved	None posted
Aug 29, 2011	Supplement 12Labeling	Approved	None posted
Oct 29, 2008	Supplement 6Labeling	Approved	None posted
Mar 2, 2006	Supplement 2Labeling	Approved	None posted
Sep 13, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 77086
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters