Last Updated: November 9, 2026

Details for New Drug Application (NDA): 204964

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NDA 204964 describes RUFINAMIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin, MSN, Glenmark Pharms Ltd, Micro Labs, and Sciegen Pharms, and is included in fifteen NDAs. It is available from eleven suppliers. Additional details are available on the RUFINAMIDE profile page.

The generic ingredient in RUFINAMIDE is rufinamide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 204964
Tradename:RUFINAMIDE
Applicant:Lupin
Ingredient:rufinamide
Patents:0
Suppliers and Packaging for NDA: 204964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUFINAMIDE rufinamide TABLET;ORAL 204964 ANDA Lupin Pharmaceuticals, Inc. 68180-803 68180-803-16 120 TABLET, FILM COATED in 1 BOTTLE (68180-803-16)
RUFINAMIDE rufinamide TABLET;ORAL 204964 ANDA Lupin Pharmaceuticals, Inc. 68180-804 68180-804-16 120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 17, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 17, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Aug 17, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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