Application 218213
- Type
- NDA
- Sponsor
- BRISTOL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUGTYRO | REPOTRECTINIB | CAPSULE;ORAL | 40MG | Yes | Yes |
| 002 | AUGTYRO | REPOTRECTINIB | CAPSULE;ORAL | 160MG | Yes | Yes |
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AUGTYRO | REPOTRECTINIB | CAPSULE;ORAL | 40MG | Yes | Yes |
| 002 | AUGTYRO | REPOTRECTINIB | CAPSULE;ORAL | 160MG | Yes | Yes |