Leflunomide

Treats active rheumatoid arthritis (RA). ANDA 91369, held by Alembic Pharms Ltd. Leflunomide.

As of Nov 14, 2026, ANDA 91369 (Leflunomide), held by Alembic Pharms Ltd, was first approved by FDA on Nov 21, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 21, 2011
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Nov 21, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Sep 23, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Sep 23, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Nov 21, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91369
Drugs@FDA: Overview at FDA
Company: Alembic 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