NDA 20900, held by Dxs Devices. Urea C-13.
As of Nov 13, 2026, NDA 20900 (Pylori-Chek Breath Test), held by Dxs Devices, was first approved by FDA on Feb 4, 1999, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 1999 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pylori-Chek Breath Test100MG/VIAL · for solution;oral | Urea C-13 | 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
