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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213328


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NDA 213328 describes TEMOZOLOMIDE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chemi Spa, Deva Holding As, Eirgen, Extrovis, Heritage, Hetero Labs Ltd V, Nivagen Pharms Inc, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the TEMOZOLOMIDE profile page.

The generic ingredient in TEMOZOLOMIDE is temozolomide. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 213328
Tradename:TEMOZOLOMIDE
Applicant:Nivagen Pharms Inc
Ingredient:temozolomide
Patents:0
Pharmacology for NDA: 213328
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 213328
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 213328 ANDA Nivagen Pharmaceuticals, Inc. 75834-132 75834-132-05 1 BOTTLE in 1 CARTON (75834-132-05) / 5 CAPSULE in 1 BOTTLE
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 213328 ANDA Nivagen Pharmaceuticals, Inc. 75834-132 75834-132-14 1 CARTON in 1 CARTON (75834-132-14) / 1 CAPSULE in 1 CARTON

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Nov 23, 2021TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG
Approval Date:Nov 23, 2021TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Nov 23, 2021TE:RLD:No

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Preferred Citation:

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