NH3N13

FDA Drug Profile — Ammonia N 13

Drug Details

Generic Name
NH3N13
Brand Names
Ammonia N 13
Application Number
NDA022119
Sponsor
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
NDC Codes
5
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
AMMONIA N-13

Indications and Usage

1 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 ( 1 ).