NDA 50459, held by Glaxosmithkline. Amoxicillin.
As of Nov 14, 2026, NDA 50459 (Amoxil), held by Glaxosmithkline, was first approved by FDA on Jan 18, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 1974 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Amoxil250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Amoxicillin | DiscontinuedReference drug |
| Amoxil500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Amoxicillin | DiscontinuedReference drug |
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
