temozolomide 5 MG Oral Capsule
1 INDICATIONS AND USAGE Temozolomide capsules are 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 Temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma Temozolomide capsules are indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.
Amneal Pharmaceuticals LLC
CAPSULE GREEN AMNEAL 801
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16 HOW SUPPLIED/STORAGE AND HANDLING
TEMOZOLOMIDE capsules USP, is a hazardous 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 USP, 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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