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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 209613


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NDA 209613 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 209613
Tradename:TERIFLUNOMIDE
Applicant:Amneal Pharms Co
Ingredient:teriflunomide
Patents:0
Pharmacology for NDA: 209613
Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors
Suppliers and Packaging for NDA: 209613
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209613 ANDA Amneal Pharmaceuticals NY LLC 69238-1303 69238-1303-2 2 BLISTER PACK in 1 CARTON (69238-1303-2) / 14 TABLET, FILM COATED in 1 BLISTER PACK
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209613 ANDA Amneal Pharmaceuticals NY LLC 69238-1303 69238-1303-6 28 TABLET, FILM COATED in 1 BOTTLE (69238-1303-6)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7MG
Approval Date:Sep 28, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength14MG
Approval Date:Sep 28, 2018TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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