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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 201528


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NDA 201528 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 eight 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. Nine suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Summary for 201528
Tradename:TEMOZOLOMIDE
Applicant:Accord Hlthcare
Ingredient:temozolomide
Patents:0
Pharmacology for NDA: 201528
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 201528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-048 16729-048-53 1 BOTTLE, GLASS in 1 CARTON (16729-048-53) / 5 CAPSULE in 1 BOTTLE, GLASS
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528 ANDA Accord Healthcare Inc. 16729-048 16729-048-54 1 BOTTLE, GLASS in 1 CARTON (16729-048-54) / 14 CAPSULE in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Feb 27, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Feb 27, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 27, 2017TE:ABRLD:No

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Preferred Citation:

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