APPLICATION
ANDA209526
TYPE
ANDA
ORIGINAL APPROVAL
2026-07-20
LATEST ACTION
2026-07-20
ROUTE
INJECTION, INTRAVENOUS
DOSAGE FORM
INJECTABLE, POWDER
MARKETING STATUS
None (Tentative Approval), Prescription
Products
CARFILZOMIBNone (Tentative Approval)
CARFILZOMIB 30MG · INJECTABLE · INJECTION
CARFILZOMIBNone (Tentative Approval)
CARFILZOMIB 60MG · INJECTABLE · INJECTION
CARFILZOMIBPrescription
CARFILZOMIB 60MG/VIAL · POWDER · INTRAVENOUS
Approval history
2026-07-20UNKNOWN · Original · standardAP
2026-07-20UNKNOWN · Original · standardTA
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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