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Last Updated: December 12, 2025

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 Ltd, MSN, Glenmark Pharms Ltd, Micro Labs, and Pharmobedient, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the RUFINAMIDE profile page.

The generic ingredient in RUFINAMIDE is rufinamide. There are seven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the rufinamide profile page.

Summary for 204964

Tradename:	RUFINAMIDE
Applicant:	Lupin Ltd
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:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 17, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 17, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Aug 17, 2022	TE:	AB	RLD:	No

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