Last Updated: September 24, 2026

Details for New Drug Application (NDA): 217281


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NDA 217281 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 is one drug master file entry for this compound. Nineteen 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
Pharmacology for NDA: 217281
Suppliers and Packaging for NDA: 217281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENALIDOMIDE lenalidomide CAPSULE;ORAL 217281 ANDA Novugen Pharma (USA) LLC 82293-006 82293-006-10 28 CAPSULE in 1 BOTTLE (82293-006-10)
LENALIDOMIDE lenalidomide CAPSULE;ORAL 217281 ANDA Novugen Pharma (USA) LLC 82293-007 82293-007-10 28 CAPSULE in 1 BOTTLE (82293-007-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Sep 11, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Sep 11, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 11, 2024TE:ABRLD:No

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Preferred Citation:

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