sorafenib tosylate sorafenib tablet film coated
1 INDICATIONS AND USAGE Sorafenib tablets are a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment ( 1.3 ) 1.1 hepatocellular carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.2 Renal Cell Carcinoma Sorafenib tablets are indicated for the treatment of patients with Advanced renal cell carcinoma (RCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.
mylan pharmaceuticals inc.
ROUND ORANGE NAT 200
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16 HOW SUPPLIED/STORAGE AND HANDLING
SORAFENIB Tablets, USP are available containing 200 mg
SORAFENIB equivalent to 274 mg
SORAFENIB tosylate, USP. The 200 mg tablets are peach, film-coated, round, unscored tablets debossed with 200 on one side of the tablet and NAT on the other side. They are available as follows: NDC 0378-1201-78 bottles of 120 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in a dry place. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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