Treats chronic hepatitis B virus infection. ANDA 212126, held by Brightgene. Entecavir.
As of Nov 15, 2026, ANDA 212126 (Entecavir), held by Brightgene, was first approved by FDA on Sep 25, 2019, with 0 approved supplements and 0 published complete response letters.
Entecavir tablets are 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 |
|---|---|---|---|
| Sep 25, 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
