Last Updated: November 13, 2026

Details for New Drug Application (NDA): 205075

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NDA 205075 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 205075

Tradename:	RUFINAMIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	rufinamide
Patents:	0

Suppliers and Packaging for NDA: 205075

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RUFINAMIDE	rufinamide	TABLET;ORAL	205075	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-713	68462-713-05	500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05)
RUFINAMIDE	rufinamide	TABLET;ORAL	205075	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-713	68462-713-08	120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 16, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 16, 2016	TE:	AB	RLD:	No

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