Treats chronic hepatitis B virus infection. ANDA 205740, held by Hetero Labs Ltd V. Entecavir.
As of Nov 15, 2026, ANDA 205740 (Entecavir), held by Hetero Labs Ltd V, was first approved by FDA on Aug 21, 2015, with 2 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 |
|---|---|---|---|
| Aug 21, 2015 | Original application | Approved | None posted |
| May 31, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 31, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 21, 2015 | 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
