Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022345
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTIGA | EZOGABINE | 50MG | TABLET;ORAL | Discontinued | None | Yes | No |
| POTIGA | EZOGABINE | 200MG | TABLET;ORAL | Discontinued | None | Yes | No |
| POTIGA | EZOGABINE | 300MG | TABLET;ORAL | Discontinued | None | Yes | No |
| POTIGA | EZOGABINE | 400MG | TABLET;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/20/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf | |
| 05/26/2015 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf | |
| 09/06/2013 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf | |
| 06/06/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf | |
| 03/19/2012 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf | |
| 03/19/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf | |
| 03/19/2012 | SUPPL-1 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf | |
| 06/10/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf |