APPLICATION
NDA212576
TYPE
NDA
ORIGINAL APPROVAL
2020-07-07
LATEST ACTION
2026-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
INQOVI · ReferencePrescription
CEDAZURIDINE 100MG, DECITABINE 35MG · TABLET · ORAL
Approval history
2020-07-07Type 1 - New Molecular Entity and Type 4 - New Combination · 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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