Details for New Drug Application (NDA): 214009
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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 214009
Tradename: | RUFINAMIDE |
Applicant: | Chartwell Rx |
Ingredient: | rufinamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Nov 7, 2022 | TE: | AB | RLD: | No |
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