temozolomide
temozolomide is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including TEMOZOLOMIDE, temozolomide. Available dosage forms: capsule, injection, powder, lyophilized, for solution, powder.
Drug Details
- Generic Name
- temozolomide
- Brand Names
- TEMOZOLOMIDE, temozolomide
- Application Number
- ANDA206309
- Sponsor
- Rising Pharma Holdings, Inc.
- NDC Codes
- 14
- Dosage Forms
- CAPSULE, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
- Routes
- ORAL
- Active Ingredients
- TEMOZOLOMIDE
Indications and Usage
1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults 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 TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMODAR is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.