APPLICATION
ANDA213912
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-30
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LENALIDOMIDEPrescription
LENALIDOMIDE 2.5MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 15MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 5MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 20MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 25MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 10MG · CAPSULE · ORAL
Approval history
2026-04-27REMS · Supplement 6AP
2023-03-24REMS · Supplement 2AP
2023-03-06UNKNOWN · 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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