APPLICATION
NDA219389
TYPE
NDA
ORIGINAL APPROVAL
2025-02-11
LATEST ACTION
2025-02-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GOMEKLI · ReferencePrescription
MIRDAMETINIB 2MG · CAPSULE · ORAL
GOMEKLI · ReferencePrescription
MIRDAMETINIB 1MG · CAPSULE · ORAL
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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