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FDA Drug information

Temozolomide

Read time: 1 mins
Marketing start date: 22 Jul 2024

Summary of product characteristics


Effective Time

20221017

Version

5

Spl Product Data Elements

temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER GREEN WHITE CAPSULE 751 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER YELLOW WHITE CAPSULE 752 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ANHYDROUS LACTOSE SODIUM STARCH GLYCOLATE TYPE B POTATO TARTARIC ACID STEARIC ACID BUTYL ALCOHOL ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC AMMONIA WATER GELATIN TITANIUM DIOXIDE SODIUM LAURYL SULFATE FD&C RED NO. 3 D&C YELLOW NO. 10 SILICON DIOXIDE PINK WHITE CAPSULE 753 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FD&C BLUE NO. 1 FD&C RED NO. 3 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER BLUE WHITE CAPSULE 754 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER ORANGE WHITE CAPSULE 755 temozolomide temozolomide TEMOZOLOMIDE TEMOZOLOMIDE ALCOHOL AMMONIA ANHYDROUS LACTOSE BUTYL ALCOHOL FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE B POTATO STEARIC ACID TARTARIC ACID TITANIUM DIOXIDE WATER WHITE WHITE CAPSULE 756

Application Number

ANDA206750

Brand Name

Temozolomide

Generic Name

temozolomide

Product Ndc

70771-1095

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1092-6 in bottle of 5 capsules Temozolomide Capsules, 5 mg R x only 5 capsules NDC 70771-1093-6 in bottle of 5 capsules Temozolomide Capsules, 20 mg R x only 5 capsules NDC 70771-1094-6 in bottle of 5 capsules Temozolomide Capsules, 100 mg R x only 5 capsules NDC 70771-1095-6 in bottle of 5 capsules Temozolomide Capsules, 140 mg R x only 5 capsules NDC 70771-1096-6 in bottle of 5 capsules Temozolomide Capsules, 180 mg R x only 5 capsules NDC 70771-1097-6 in bottle of 5 capsules Temozolomide Capsules, 250 mg R x only 5 capsules Temozolomide capsules, 5 mg Temozolomide capsules, 20 mg Temozolomide capsules, 100 mg Temozolomide capsules, 140 mg Temozolomide capsules, 180 mg Temozolomide capsules, 250 mg

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