APPLICATION
ANDA209956
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-04
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
POMALIDOMIDEPrescription
POMALIDOMIDE 4MG · CAPSULE · ORAL
POMALIDOMIDEPrescription
POMALIDOMIDE 2MG · CAPSULE · ORAL
POMALIDOMIDEPrescription
POMALIDOMIDE 3MG · CAPSULE · ORAL
POMALIDOMIDEPrescription
POMALIDOMIDE 1MG · CAPSULE · ORAL
Approval history
2026-04-27REMS · Supplement 9AP
2026-03-12Labeling · Supplement 3 · standardAP
2025-08-05REMS · Supplement 1AP
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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