You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 216688

✉ Email this page to a colleague

« Back to Dashboard

NDA 216688 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.