Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011366
Company: XERIS
Company: XERIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DARANIDE | DICHLORPHENAMIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| KEVEYIS | DICHLORPHENAMIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/22/2019 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Label and Letter for KEVEYIS | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011366s033lbl.pdf |
| 08/07/2015 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | Label and Letter for KEVEYIS | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011366s030lbl.pdf |