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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 201452


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NDA 201452 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 201452
Tradename:LENALIDOMIDE
Applicant:Arrow Intl
Ingredient:lenalidomide
Patents:0
Pharmacology for NDA: 201452
Suppliers and Packaging for NDA: 201452
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENALIDOMIDE lenalidomide CAPSULE;ORAL 201452 ANDA Teva Pharmaceuticals, Inc. 0480-1241 0480-1241-28 28 CAPSULE in 1 BOTTLE (0480-1241-28)
LENALIDOMIDE lenalidomide CAPSULE;ORAL 201452 ANDA Teva Pharmaceuticals, Inc. 0480-1242 0480-1242-28 28 CAPSULE in 1 BOTTLE (0480-1242-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:May 21, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 21, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:May 21, 2021TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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