temozolomide 250 MG Oral Capsule
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 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.
Amneal Pharmaceuticals LLC
CAPSULE WHITE AMNEAL 806
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16 HOW SUPPLIED/STORAGE AND HANDLING
TEMOZOLOMIDE is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
TEMOZOLOMIDE capsules USP, 5 mg, are supplied as size “3” hard gelatin capsules with green opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “801” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-801-51 Bottles of 14: NDC 65162-801-14
TEMOZOLOMIDE capsules USP, 20 mg, are supplied as size “2” hard gelatin capsules with yellow opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “802” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-802-51 Bottles of 14: NDC 65162-802-14
TEMOZOLOMIDE capsules USP, 100 mg, are supplied as size “1” hard gelatin capsules with pink opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “803” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-803-51 Bottles of 14: NDC 65162-803-14
TEMOZOLOMIDE capsules USP, 140 mg, are supplied as size “0” hard gelatin capsules with blue opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “804” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-804-51 Bottles of 14: NDC 65162-804-14
TEMOZOLOMIDE capsules USP, 180 mg, are supplied as size “0” hard gelatin capsules with red opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “805” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-805-51 Bottles of 14: NDC 65162-805-14
TEMOZOLOMIDE capsules USP, 250 mg, are supplied as size “0” hard gelatin capsules with white opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “806” with black ink. They are supplied as follows: Bottles of 5: NDC 65162-806-51 Store
TEMOZOLOMIDE capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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