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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 204993


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NDA 204993 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 204993
Tradename:RUFINAMIDE
Applicant:Hetero Labs Ltd Iii
Ingredient:rufinamide
Patents:0
Suppliers and Packaging for NDA: 204993
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUFINAMIDE rufinamide TABLET;ORAL 204993 ANDA Camber Pharmaceuticals, Inc. 31722-598 31722-598-12 120 TABLET, FILM COATED in 1 BOTTLE (31722-598-12)
RUFINAMIDE rufinamide TABLET;ORAL 204993 ANDA Camber Pharmaceuticals, Inc. 31722-598 31722-598-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-598-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 11, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:May 11, 2021TE:ABRLD:No

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