Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213410
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/23/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
RUFINAMIDE
SUSPENSION;ORAL; 40MG/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BANZEL | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 201367 | EISAI INC |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213410 | ALKEM LABS LTD |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 216549 | AUROBINDO PHARMA |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 211388 | BIONPHARMA |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 214009 | CHARTWELL RX |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 216841 | HETERO LABS LTD III |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 207363 | HIKMA |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213457 | LUPIN LTD |