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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216549


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NDA 216549 describes RUFINAMIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Micro Labs, and Mylan, and is included in fourteen NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 216549
Tradename:RUFINAMIDE
Applicant:Aurobindo Pharma
Ingredient:rufinamide
Patents:0
Suppliers and Packaging for NDA: 216549
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUFINAMIDE rufinamide SUSPENSION;ORAL 216549 ANDA Aurobindo Pharma Limited 59651-563 59651-563-60 1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Oct 26, 2022TE:ABRLD:No

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