Treats chronic hepatitis B virus infection. ANDA 208195, held by Yung Shin Pharm. Entecavir.
As of Nov 15, 2026, ANDA 208195 (Entecavir), held by Yung Shin Pharm, was first approved by FDA on Nov 10, 2021, with 1 approved supplement 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 |
|---|---|---|---|
| Nov 10, 2021 | Original application | Approved | None posted |
| Dec 23, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Nov 10, 2021 | 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
