NDA 21314, held by Meridian Bioscience. Citric Acid; Urea C-13.
As of Nov 14, 2026, NDA 21314 (Idkit:Hp), held by Meridian Bioscience, was first approved by FDA on Dec 17, 2002, with 6 approved supplements and 0 published complete response letters.
IDkit Hp One and IDkit Hp Two are indicated for use as a diagnostic aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori (H. pylori) infection in adults and pediatric patients 3 years of age and older. IDkit Hp One and IDkit Hp Two are to be administered only by trained personnel as ordered by a licensed healthcare practitioner using the BreathID system device as identified in the BreathID system device labeling. IDkit Hp One and
| Jul 24, 2026 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 17, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Idkit:Hp4GM;75MG · for solution, tablet, for solution;oral | Citric Acid; Urea C-13 | RxReference drug |
| Jul 24, 2026 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 8, 2016 | Supplement 5Manufacturing · Standard review | Approved | |
| Oct 28, 2014 | Supplement 4Labeling · Standard review | Approved | |
| Jan 18, 2013 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 26, 2010 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 17, 2002 | 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
