Treats chronic hepatitis B virus infection. ANDA 212201, held by Yaopharma Co Ltd. Entecavir.
As of Nov 15, 2026, ANDA 212201 (Entecavir), held by Yaopharma Co Ltd, was first approved by FDA on Nov 4, 2019, with 0 approved supplements and 0 published complete response letters.
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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2019 | Original application | Approved | None posted |
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
