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Treats chronic hepatitis B virus infection. ANDA 216857, held by Conba USA. Entecavir.
As of Nov 15, 2026, ANDA 216857 (Entecavir), held by Conba USA, was first approved by FDA on Dec 23, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Dec 23, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (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.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
