abiraterone 500 mg
1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). (1) metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
Amneal Pharmaceuticals NY LLC
OVAL PURPLE 1754
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16 HOW SUPPLIED/STORAGE AND HANDLING
ABIRATERONE acetate tablets are available in the strengths and packages listed below:
ABIRATERONE acetate tablets USP, 250 mg , are available as white to off-white, oval-shaped, uncoated tablets debossed with “AN65” on one side and plain on the other side. They are supplied as follows: Bottles of 120: NDC 69238-1165-7
ABIRATERONE acetate tablets USP, 500 mg , are available as purple, oval-shaped, film-coated tablets debossed with “1754” on one side and plain on the other side. They are supplied as follows: Bottles of 60: NDC 69238-1754-6 Storage and Handling Store 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]. Keep out of reach of children. Based on its mechanism of action,
ABIRATERONE acetate tablets may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle
ABIRATERONE acetate 250 mg uncoated tablets or other
ABIRATERONE acetate tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations (8.1) ] .
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