APPLICATION
ANDA213405
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-17
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LENALIDOMIDEDiscontinued
LENALIDOMIDE 5MG · CAPSULE · ORAL
LENALIDOMIDEDiscontinued
LENALIDOMIDE 15MG · CAPSULE · ORAL
LENALIDOMIDEDiscontinued
LENALIDOMIDE 25MG · CAPSULE · ORAL
LENALIDOMIDEDiscontinued
LENALIDOMIDE 2.5MG · CAPSULE · ORAL
LENALIDOMIDEDiscontinued
LENALIDOMIDE 20MG · CAPSULE · ORAL
LENALIDOMIDEDiscontinued
LENALIDOMIDE 10MG · CAPSULE · ORAL
Approval history
2026-04-27REMS · Supplement 5AP
2023-08-03UNKNOWN · Original · standardAP
2023-03-24REMS · 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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