ammonia n-13

FDA Drug Profile — Ammonia N 13

Drug Details

Generic Name
ammonia n-13
Brand Names
Ammonia N 13
Application Number
ANDA207025
Sponsor
Massachusetts General Hospital
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
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) .