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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 210154


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NDA 210154 describes LENALIDOMIDE, which is a drug marketed by Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms, and is included in fourteen NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 210154
Tradename:LENALIDOMIDE
Applicant:Zydus Pharms
Ingredient:lenalidomide
Patents:0
Pharmacology for NDA: 210154
Suppliers and Packaging for NDA: 210154
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENALIDOMIDE lenalidomide CAPSULE;ORAL 210154 ANDA Zydus Pharmaceuticals USA Inc. 70710-1030 70710-1030-1 100 CAPSULE in 1 BOTTLE (70710-1030-1)
LENALIDOMIDE lenalidomide CAPSULE;ORAL 210154 ANDA Zydus Pharmaceuticals USA Inc. 70710-1030 70710-1030-7 28 CAPSULE in 1 BOTTLE (70710-1030-7)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Sep 12, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 12, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Sep 12, 2022TE:ABRLD:No

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