For suspected or existing coronary artery disease. NDA 22119, held by Feinstein. Ammonia N-13.
As of Nov 13, 2026, NDA 22119 (Ammonia N 13), held by Feinstein, was first approved by FDA on Aug 23, 2007, with 1 approved supplement and 0 published complete response letters.
Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2007 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ammonia N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML) · injectable;intravenous | Ammonia N-13 | RxReference drug |
| Jan 5, 2011 | Supplement 1Labeling | Approved | |
| Aug 23, 2007 | Original applicationNew molecular entity · 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
