TheraRadar
Data updated: May 26, 2026

AMMONIA N 13 (ammonia n-13)

Radiopharmaceutical Activity
Cardiovascular Approved 2007-08-23

AMMONIA N 13 is indicated for the treatment of Coronary Artery Disease.

Source: FDA Label • BIOMEDCL RES FDN
30
Indications
--
Phase 3 Trials
18
Years on Market

AMMONIA N 13 Approval History

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
40 FDA actions from 2007 to 2026
Feb 2026 SUPPL
Mfg · Manufacturing (CMC)
May 2023 SUPPL
Mfg · Manufacturing (CMC)
Nov 2022 ORIGINAL
Update

What AMMONIA N 13 Treats

1 indications

AMMONIA N 13 is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Coronary Artery Disease
Source: FDA Label

AMMONIA N 13 Competitive Set

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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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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 is indicated for the treatment of Coronary Artery Disease.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.