Last Updated: June 9, 2026

Details for New Drug Application (NDA): 217265


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NDA 217265 describes LENALIDOMIDE, which is a drug marketed by Accord Hlthcare, Alvogen, Amneal, Apotex, Arrow Intl, Biocon Pharma, Cipla, Deva Holding As, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lupin, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms, and is included in twenty NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 217265
Tradename:LENALIDOMIDE
Applicant:Qilu
Ingredient:lenalidomide
Patents:0
Pharmacology for NDA: 217265
Suppliers and Packaging for NDA: 217265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENALIDOMIDE lenalidomide CAPSULE;ORAL 217265 ANDA Padagis US LLC 0574-1402 0574-1402-28 28 CAPSULE in 1 BOTTLE (0574-1402-28)
LENALIDOMIDE lenalidomide CAPSULE;ORAL 217265 ANDA Padagis US LLC 0574-1405 0574-1405-28 28 CAPSULE in 1 BOTTLE (0574-1405-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Feb 22, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Feb 22, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Feb 22, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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