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Application 022345
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTIGA | EZOGABINE | TABLET;ORAL | 50MG | Yes | No |
| 002 | POTIGA | EZOGABINE | TABLET;ORAL | 200MG | Yes | No |
| 003 | POTIGA | EZOGABINE | TABLET;ORAL | 300MG | Yes | No |
| 004 | POTIGA | EZOGABINE | TABLET;ORAL | 400MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0173-0810 | POTIGA | ezogabine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0812 | POTIGA | ezogabine | GlaxoSmithKline LLC | NDA | Current |
| 0173-0814 | POTIGA | ezogabine | GlaxoSmithKline LLC | NDA | Current |