ANDA 205274, held by Hikma. Amoxicillin.
As of Nov 13, 2026, ANDA 205274 (Amoxicillin), held by Hikma, was first approved by FDA on Jun 25, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amoxicillin125MG · tablet, chewable;oral | Amoxicillin | Discontinued |
| Amoxicillin250MG · tablet, chewable;oral | Amoxicillin | Discontinued |
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
