APPLICATION
ANDA214824
TYPE
ANDA
ORIGINAL APPROVAL
2025-02-14
LATEST ACTION
2025-07-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
SUNITINIB MALATEPrescription
SUNITINIB MALATE EQ 12.5MG BASE · CAPSULE · ORAL
SUNITINIB MALATEPrescription
SUNITINIB MALATE EQ 50MG BASE · CAPSULE · ORAL
SUNITINIB MALATEPrescription
SUNITINIB MALATE EQ 25MG BASE · CAPSULE · ORAL
SUNITINIB MALATEPrescription
SUNITINIB MALATE EQ 37.5MG BASE · CAPSULE · ORAL
Approval history
2025-07-22Manufacturing (CMC) · Supplement 1 · unknownAP
2025-02-14UNKNOWN · Original · standardAP
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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