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FDA ANDA · ANDA217554

LENALIDOMIDE

Sponsor: DEVA HOLDING AS

APPLICATION
ANDA217554
TYPE
ANDA
ORIGINAL APPROVAL
2025-05-22
LATEST ACTION
2026-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LENALIDOMIDEPrescription
LENALIDOMIDE 20MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 10MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 2.5MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 25MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 15MG · CAPSULE · ORAL
LENALIDOMIDEPrescription
LENALIDOMIDE 5MG · CAPSULE · ORAL

Approval history

2026-04-27REMS · Supplement 4AP
2025-05-22UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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