Last Updated: November 8, 2026

Details for New Drug Application (NDA): 209583

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NDA 209583 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Speclt, Hetero Labs Ltd V, MSN, Natco, Neocubes Pharma, Sandoz, Sola Pharms, Somerset Theraps Llc, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen NDAs. It is available from sixteen suppliers. Additional details are available on the TERIFLUNOMIDE profile page.

The generic ingredient in TERIFLUNOMIDE is teriflunomide. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

Summary for 209583

Tradename:	TERIFLUNOMIDE
Applicant:	Breckenridge
Ingredient:	teriflunomide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7MG
Approval Date:	Sep 24, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	14MG
Approval Date:	Sep 24, 2021	TE:		RLD:	No

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