Last Updated: November 9, 2026

Details for New Drug Application (NDA): 214009

NDA 214009 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 214009

Tradename:	RUFINAMIDE
Applicant:	Chartwell Rx
Ingredient:	rufinamide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Nov 7, 2022	TE:	AB	RLD:	No

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