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ENTECAVIR ANHYDROUS

FDA Drug Profile — ENTECAVIR

Drug Details

Generic Name
ENTECAVIR ANHYDROUS
Brand Names
ENTECAVIR
Application Number
ANDA216857
Sponsor
Cameron Pharmaceuticals
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ENTECAVIR ANHYDROUS

Indications and Usage

1 INDICATIONS AND USAGE Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 )