NDA 50813, held by Pragma. Amoxicillin.
As of Nov 13, 2026, NDA 50813 (Moxatag), held by Pragma, was first approved by FDA on Jan 23, 2008, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Moxatag775MG · tablet, extended release;oral | Amoxicillin | DiscontinuedReference drug |
| May 1, 2024 | Supplement 10Labeling · Standard review | Approved | |
| May 17, 2022 | Supplement 9Labeling · Standard review | Approved | |
| Nov 6, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Jun 9, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Jan 23, 2008 | Original applicationNew dosage form · Standard review | Approved |
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
