ANDA 80098, held by Hexcel. Potassium Aminosalicylate.
As of Nov 15, 2026, ANDA 80098 (Potassium Aminosalicylate), held by Hexcel, was first approved by FDA on Apr 14, 1971, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 1971 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Aminosalicylate100% ยท powder;oral | Potassium Aminosalicylate | 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
