APPLICATION
ANDA210275
TYPE
ANDA
ORIGINAL APPROVAL
2022-01-26
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
POMALIDOMIDEDiscontinued
POMALIDOMIDE 2MG · CAPSULE · ORAL
POMALIDOMIDEDiscontinued
POMALIDOMIDE 3MG · CAPSULE · ORAL
POMALIDOMIDEDiscontinued
POMALIDOMIDE 1MG · CAPSULE · ORAL
POMALIDOMIDEDiscontinued
POMALIDOMIDE 4MG · CAPSULE · ORAL
Approval history
2026-04-27REMS · Supplement 5AP
2025-10-17Labeling · Supplement 3 · standardAP
2025-08-05REMS · Supplement 2AP
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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