Orange Book product · Generic (ANDA)
LENALIDOMIDE
LENALIDOMIDE
At a glance
Feb 10, 2026
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
LENALIDOMIDE
Strength
2.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 213405
Product number
005
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LENALIDOMIDE
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ANDA 218872 · ACCORD HLTHCARE
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ANDA 214398 · LUPIN
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ANDA 217554 · DEVA HOLDING AS
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ANDA 215759 · BIOCON PHARMA
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ANDA 216213 · AMNEAL
- 2024LENALIDOMIDEGeneric (ANDA)
ANDA 217281 · NOVUGEN
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ANDA 217265 · QILU
- 2023LENALIDOMIDEGeneric (ANDA)
ANDA 212414 · HETERO LABS LTD V
- 2023LENALIDOMIDEGeneric (ANDA)
ANDA 211022 · APOTEX
- 2023LENALIDOMIDEGeneric (ANDA)
ANDA 210480 · ALVOGEN
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

