Details for New Drug Application (NDA): 216549
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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: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Oct 26, 2022 | TE: | AB | RLD: | No |
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