Details for New Drug Application (NDA): 204993
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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 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: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | May 11, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | May 11, 2021 | TE: | AB | RLD: | No |
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