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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217554

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NDA 217554 describes LENALIDOMIDE, which is a drug marketed by Amneal, Apotex, Arrow Intl, Biocon Pharma, Cipla, Deva Holding As, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Lupin Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms, and is included in eighteen NDAs. It is available from fourteen suppliers. Additional details are available on the LENALIDOMIDE profile page.

The generic ingredient in LENALIDOMIDE is lenalidomide. There are fourteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.

Summary for 217554

Tradename:	LENALIDOMIDE
Applicant:	Deva Holding As
Ingredient:	lenalidomide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	May 22, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	May 22, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	May 22, 2025	TE:	AB	RLD:	No

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