FdaApplication
NDA 219943
Identifiers
- fda_app_no: NDA219943
Properties
| Property | Value |
|---|---|
| applicant_name | ASTRAZENECA PHARMACEUTICALS LP |
| application_type | NDA |
| approval_date | 2025-09-10 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KOSELUGO | SELUMETINIB | 10MG | CAPSULE;ORAL |
| KOSELUGO | SELUMETINIB | 25MG | CAPSULE;ORAL |
| KOSELUGO | SELUMETINIB SULFATE | EQ 7.5MG BASE | GRANULE;ORAL |
| KOSELUGO | SELUMETINIB SULFATE | EQ 5MG BASE | GRANULE;ORAL |
4 products