Ammonia N 13

For suspected or existing coronary artery disease. ANDA 204506, held by Wa Univ Sch Med. Ammonia N-13.

As of Nov 15, 2026, ANDA 204506 (Ammonia N 13), held by Wa Univ Sch Med, was first approved by FDA on Feb 7, 2014, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 7, 2014
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ammonia N 13 Injection USP 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 USP 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 7, 2014	Original application	Approved	None posted

Products

2 strengths and forms


Ammonia N 1330mCi-300mCi/8ML (3.75-37.5mCi/ML) · injectable;intravenous	Ammonia N-13	Rx
Ammonia N 1337.5mCi-800mCi/10ML (3.75-80mCi/ML) · injectable;intravenous	Ammonia N-13	Rx

All 2 submissions, including labeling and manufacturing supplements


Feb 13, 2026	Supplement 4Manufacturing	Approved	None posted
Feb 7, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 204506
Drugs@FDA: Overview at FDA
Company: Wa Univ Sch Med

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