Application Nr Approved Date Route Status External Links
ANDA204639 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Temozolomide Capsules Are An Alkylating Drug Indicated For The Treatment Of Adult Patients With: Newly Diagnosed Glioblastoma Concomitantly With Radiotherapy And Then As Maintenance Treatment (1.1) Refractory Anaplastic Astrocytoma Patients Who Have Experienced Disease Progression On A Drug Regimen Containing Nitrosourea And Procarbazine. (1.2) 1.1 Newly Diagnosed Glioblastoma Temozolomide Capsules Are Indicated For The Treatment Of Adult Patients With Newly Diagnosed Glioblastoma Concomitantly With Radiotherapy And Then As Maintenance Treatment. 1.2 Refractory Anaplastic Astrocytoma Temozolomide Capsules Are Indicated For The Treatment Of Adult Patients With Refractory Anaplastic Astrocytoma Who Have Experienced Disease Progression On A Drug Regimen Containing Nitrosourea And Procarbazine.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Temozolomide TEMOZOLOMIDE ZINC1482184

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