ANDA 205824, held by Accord Hlthcare. Entecavir.
As of Nov 15, 2026, ANDA 205824 (Entecavir), held by Accord Hlthcare, was first approved by FDA on Aug 25, 2017, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2017 | Original application | Approved | None posted |
| Aug 25, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 23, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 23, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 25, 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
