Application 219943
- Type
- NDA
- Sponsor
- ASTRAZENECA
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KOSELUGO | SELUMETINIB SULFATE | GRANULE;ORAL | EQ 5MG BASE | Yes | No |
| 002 | KOSELUGO | SELUMETINIB SULFATE | GRANULE;ORAL | EQ 7.5MG BASE | Yes | Yes |
| 003 | KOSELUGO | SELUMETINIB | CAPSULE; ORAL | 10MG | No | No |
| 004 | KOSELUGO | SELUMETINIB | CAPSULE; ORAL | 25MG | No | No |