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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209601

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NDA 209601 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Concord Biotech Ltd, Glenmark Speclt, Hetero Labs Ltd V, MSN, Natco, 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 eighteen suppliers. Additional details are available on the TERIFLUNOMIDE profile page.

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

Summary for 209601

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7MG
Approval Date:	Nov 2, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	14MG
Approval Date:	Nov 2, 2018	TE:		RLD:	No

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