Details for New Drug Application (NDA): 213410
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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 213410
Tradename: | RUFINAMIDE |
Applicant: | Alkem Labs Ltd |
Ingredient: | rufinamide |
Patents: | 0 |
Suppliers and Packaging for NDA: 213410
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 213410 | ANDA | Ascend Laboratories, LLC | 67877-673 | 67877-673-62 | 1 BOTTLE in 1 CARTON (67877-673-62) / 460 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Feb 23, 2021 | TE: | AB | RLD: | No |
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