AMMONIA N 13 (ammonia n-13) · NUKEMED
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.
Details
- Status
- Discontinued
- First Approved
- 2007-08-23
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
Companies
AMMONIA N 13 Approval History
What AMMONIA N 13 Treats
1 indicationsAMMONIA N 13 is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
AMMONIA N 13 Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMMONIA N 13 FDA Label Details
Indications & Usage
FDA Label (PDF)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 .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.