Treats chronic hepatitis B virus infection. ANDA 206745, held by Zydus Pharms. Entecavir.
As of Nov 15, 2026, ANDA 206745 (Entecavir), held by Zydus Pharms, was first approved by FDA on Jun 23, 2017, with 4 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2017 | Original application | Approved | None posted |
| Jun 18, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 4, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 4, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 4, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 23, 2017 | 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
