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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209348


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NDA 209348 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 209348
Tradename:LENALIDOMIDE
Applicant:Dr Reddys
Ingredient:lenalidomide
Patents:0
Pharmacology for NDA: 209348
Suppliers and Packaging for NDA: 209348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENALIDOMIDE lenalidomide CAPSULE;ORAL 209348 ANDA Dr. Reddy's Laboratories Inc. 43598-511 43598-511-01 100 CAPSULE in 1 BOTTLE (43598-511-01)
LENALIDOMIDE lenalidomide CAPSULE;ORAL 209348 ANDA Dr. Reddy's Laboratories Inc. 43598-511 43598-511-63 28 CAPSULE in 1 BOTTLE (43598-511-63)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Oct 14, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Oct 14, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 30, 2022TE:ABRLD:No

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Preferred Citation:

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