Last Updated: November 9, 2026

Details for New Drug Application (NDA): 216688

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NDA 216688 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 216688

Tradename:	RUFINAMIDE
Applicant:	Micro Labs
Ingredient:	rufinamide
Patents:	0

Suppliers and Packaging for NDA: 216688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RUFINAMIDE	rufinamide	TABLET;ORAL	216688	ANDA	Micro Labs Limited	42571-391	42571-391-12	120 TABLET in 1 BOTTLE (42571-391-12)
RUFINAMIDE	rufinamide	TABLET;ORAL	216688	ANDA	Micro Labs Limited	42571-392	42571-392-12	120 TABLET in 1 BOTTLE (42571-392-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 15, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 15, 2023	TE:	AB	RLD:	No

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