Application 219389
- Type
- NDA
- Sponsor
- SPRINGWORKS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GOMEKLI | MIRDAMETINIB | CAPSULE;ORAL | 1MG | Yes | No |
| 002 | GOMEKLI | MIRDAMETINIB | CAPSULE;ORAL | 2MG | Yes | Yes |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GOMEKLI | MIRDAMETINIB | CAPSULE;ORAL | 1MG | Yes | No |
| 002 | GOMEKLI | MIRDAMETINIB | CAPSULE;ORAL | 2MG | Yes | Yes |