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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 207363


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NDA 207363 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 nine 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. Eleven suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 207363
Tradename:RUFINAMIDE
Applicant:Hikma
Ingredient:rufinamide
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUFINAMIDE rufinamide SUSPENSION;ORAL 207363 ANDA Hikma Pharmaceuticals USA Inc. 0054-0528 0054-0528-63 1 BOTTLE in 1 CARTON (0054-0528-63) / 460 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/ML
Approval Date:Apr 23, 2019TE:ABRLD:No

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