APPLICATION
NDA214701
TYPE
NDA
ORIGINAL APPROVAL
2020-12-01
LATEST ACTION
2020-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GAVRETOPrescription
PRALSETINIB 100MG · CAPSULE · ORAL
Approval history
2020-12-01Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval · Original · priority — Label ↗AP
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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