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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 209697

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NDA 209697 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, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in eighteen NDAs. It is available from twenty 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. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

Summary for 209697

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7MG
Approval Date:	Apr 4, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	14MG
Approval Date:	Apr 4, 2024	TE:		RLD:	No

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