Details for New Drug Application (NDA): 216841
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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 216841
Tradename: | RUFINAMIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | rufinamide |
Patents: | 0 |
Suppliers and Packaging for NDA: 216841
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 216841 | ANDA | Camber Pharmaceuticals, Inc. | 31722-688 | 31722-688-46 | 1 BOTTLE in 1 CARTON (31722-688-46) / 460 mL in 1 BOTTLE |
RUFINAMIDE | rufinamide | SUSPENSION;ORAL | 216841 | ANDA | NorthStar RxLLC | 72603-261 | 72603-261-01 | 1 BOTTLE in 1 CARTON (72603-261-01) / 460 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No |
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