Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 207363
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 04/23/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207363Orig1s000ltr.pdf |
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 | 211388 | BIONPHARMA INC |
| RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 207363 | HIKMA |
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