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FDA ANDA · ANDA218872

LENALIDOMIDE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA218872
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-14
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 1AP
2025-11-14UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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