Drugs@FDA: FDA-Approved Drugs
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 |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/07/2020 | SUPPL-1 | Labeling-Package Insert |
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 | 211388 | BIONPHARMA INC |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 207363 | HIKMA |
RUFINAMIDE | RUFINAMIDE | 40MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 213457 | LUPIN LTD |
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