Details for New Drug Application (NDA): 204964
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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 204964
Tradename: | RUFINAMIDE |
Applicant: | Lupin Ltd |
Ingredient: | rufinamide |
Patents: | 0 |
Suppliers and Packaging for NDA: 204964
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RUFINAMIDE | rufinamide | TABLET;ORAL | 204964 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-803 | 68180-803-16 | 120 TABLET, FILM COATED in 1 BOTTLE (68180-803-16) |
RUFINAMIDE | rufinamide | TABLET;ORAL | 204964 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-804 | 68180-804-16 | 120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 17, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 17, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
Approval Date: | Aug 17, 2022 | TE: | AB | RLD: | No |
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