Details for New Drug Application (NDA): 209601

NDA 209601 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 209601

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

Pharmacology for NDA: 209601

Mechanism of Action

Dihydroorotate Dehydrogenase Inhibitors

Suppliers and Packaging for NDA: 209601

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209601	ANDA	Apotex Corp	60505-4477	60505-4477-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-4477-3)
TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209601	ANDA	Apotex Corp	60505-4478	60505-4478-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-4478-3)

Profile for product number 001

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

Profile for product number 002

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

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