ANDA 62528, held by Labs Atral. Amoxicillin.
As of Nov 14, 2026, ANDA 62528 (Amoxicillin), held by Labs Atral, was first approved by FDA on Aug 7, 1985, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 1985 | Original application | Approved | None posted |
| Amoxicillin250MG · capsule;oral | Amoxicillin | Discontinued |
| Amoxicillin500MG · capsule;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
