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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205095

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NDA 205095 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 205095

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

Suppliers and Packaging for NDA: 205095

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RUFINAMIDE	rufinamide	TABLET;ORAL	205095	ANDA	Mylan Pharmaceuticals Inc.	0378-2330	0378-2330-78	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2330-78)
RUFINAMIDE	rufinamide	TABLET;ORAL	205095	ANDA	Mylan Pharmaceuticals Inc.	0378-2331	0378-2331-78	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2331-78)

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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