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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 209668


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NDA 209668 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Pharms, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209668
Tradename:TERIFLUNOMIDE
Applicant:Zydus Pharms
Ingredient:teriflunomide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209668
Suppliers and Packaging for NDA: 209668
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209668 ANDA Zydus Pharmaceuticals USA Inc. 70710-1114 70710-1114-3 30 TABLET, FILM COATED in 1 BOTTLE (70710-1114-3)
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209668 ANDA Zydus Pharmaceuticals USA Inc. 70710-1114 70710-1114-8 2 CARTON in 1 CARTON (70710-1114-8) / 1 BLISTER PACK in 1 CARTON (70710-1114-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7MG
Approval Date:Nov 30, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength14MG
Approval Date:Nov 30, 2018TE:ABRLD:No

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