Details for New Drug Application (NDA): 209690

NDA 209690 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 209690

Tradename:	TERIFLUNOMIDE
Applicant:	Accord Hlthcare
Ingredient:	teriflunomide
Patents:	0

Pharmacology for NDA: 209690

Mechanism of Action

Dihydroorotate Dehydrogenase Inhibitors

Suppliers and Packaging for NDA: 209690

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690	ANDA	Accord Healthcare Inc.	16729-399	16729-399-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-399-10)
TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690	ANDA	Accord Healthcare Inc.	16729-400	16729-400-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-400-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7MG
Approval Date:	Jan 7, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	14MG
Approval Date:	Jan 7, 2019	TE:	AB	RLD:	No

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