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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210480

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NDA 210480 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 210480

Tradename:	LENALIDOMIDE
Applicant:	Lotus Pharm Co Ltd
Ingredient:	lenalidomide
Patents:	0

Pharmacology for NDA: 210480

Suppliers and Packaging for NDA: 210480

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210480	ANDA	Alvogen, Inc.	47781-483	47781-483-01	100 CAPSULE in 1 BOTTLE (47781-483-01)
LENALIDOMIDE	lenalidomide	CAPSULE;ORAL	210480	ANDA	Alvogen, Inc.	47781-483	47781-483-28	28 CAPSULE in 1 BOTTLE (47781-483-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Aug 31, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Aug 31, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Aug 31, 2022	TE:	AB	RLD:	No

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