FdaApplication
NDA 219379
Identifiers
- fda_app_no: NDA219379
Properties
| Property | Value |
|---|---|
| applicant_name | SPRINGWORKS THERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2025-02-11 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GOMEKLI | MIRDAMETINIB | 4MG | TABLET, FOR SUSPENSION;ORAL |
| GOMEKLI | MIRDAMETINIB | 1MG | TABLET, FOR SUSPENSION;ORAL |
| GOMEKLI | MIRDAMETINIB | 3MG | TABLET, FOR SUSPENSION;ORAL |
3 products