Details for New Drug Application (NDA): 216688
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NDA 216688 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 ten 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the rufinamide profile page.
Summary for 216688
| Tradename: | RUFINAMIDE |
| Applicant: | Micro Labs |
| Ingredient: | rufinamide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216688
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RUFINAMIDE | rufinamide | TABLET;ORAL | 216688 | ANDA | Micro Labs Limited | 42571-391 | 42571-391-12 | 120 TABLET in 1 BOTTLE (42571-391-12) |
| RUFINAMIDE | rufinamide | TABLET;ORAL | 216688 | ANDA | Micro Labs Limited | 42571-392 | 42571-392-12 | 120 TABLET in 1 BOTTLE (42571-392-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 15, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | May 15, 2023 | TE: | AB | RLD: | No | ||||
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