temozolomide
Drug Details
- Generic Name
- temozolomide
- Brand Names
- TEMOZOLOMIDE, temozolomide
- Application Number
- ANDA206309
- Sponsor
- Wavelength Enterprises LTD
- NDC Codes
- 14
- Dosage Forms
- POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, CAPSULE
- Routes
- ORAL
- Active Ingredients
- TEMOZOLOMIDE
Indications and Usage
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 ) Anaplastic astrocytoma ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMOZOLOMIDE Capsules is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.