APPLICATION
NDA204369
TYPE
NDA
ORIGINAL APPROVAL
2013-02-25
LATEST ACTION
2013-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
STIVARGAPrescription
REGORAFENIB 40MG · TABLET · ORAL
Approval history
2013-02-25Type 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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