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Last Updated: March 21, 2025

Details for New Drug Application (NDA): 217281

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NDA 217281 describes LENALIDOMIDE, which is a drug marketed by Amneal, Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms, and is included in fifteen NDAs. It is available from thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.

Summary for 217281

Tradename:	LENALIDOMIDE
Applicant:	Novugen
Ingredient:	lenalidomide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	Sep 11, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Sep 11, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Sep 11, 2024	TE:	AB	RLD:	No

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