Details for New Drug Application (NDA): 204988
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NDA 204988 describes RUFINAMIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Glenmark Pharms Ltd, Micro Labs, and Mylan, and is included in fourteen NDAs. It is available from nine suppliers. Additional details are available on the RUFINAMIDE profile page.
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.
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 204988
| Tradename: | RUFINAMIDE |
| Applicant: | Hikma |
| Ingredient: | rufinamide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204988
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RUFINAMIDE | rufinamide | TABLET;ORAL | 204988 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0425 | 0054-0425-23 | 120 TABLET, FILM COATED in 1 BOTTLE (0054-0425-23) |
| RUFINAMIDE | rufinamide | TABLET;ORAL | 204988 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0426 | 0054-0426-23 | 120 TABLET, FILM COATED in 1 BOTTLE (0054-0426-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 16, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | May 16, 2016 | TE: | AB | RLD: | No | ||||
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