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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 203691


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NDA 203691 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 203691
Tradename:TEMOZOLOMIDE
Applicant:Amneal Pharms
Ingredient:temozolomide
Patents:0
Pharmacology for NDA: 203691
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 203691
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691 ANDA Amneal Pharmaceuticals LLC 65162-801 65162-801-14 1 BOTTLE in 1 CARTON (65162-801-14) / 14 CAPSULE in 1 BOTTLE
TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691 ANDA Amneal Pharmaceuticals LLC 65162-801 65162-801-51 1 BOTTLE in 1 CARTON (65162-801-51) / 5 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:May 8, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:May 8, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 8, 2015TE:ABRLD:No

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Preferred Citation:

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