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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 214817

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NDA 214817 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 214817

Tradename:	RUFINAMIDE
Applicant:	Msn
Ingredient:	rufinamide
Patents:	0

Suppliers and Packaging for NDA: 214817

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RUFINAMIDE	rufinamide	SUSPENSION;ORAL	214817	ANDA	Novadoz Pharmaceuticals LLC	72205-038	72205-038-77	1 BOTTLE in 1 CARTON (72205-038-77) / 460 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	40MG/ML
Approval Date:	Apr 15, 2025	TE:	AB	RLD:	No

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