Ammonia N-13

For suspected or existing coronary artery disease. Sold as Ammonia N 13. Every FDA application for this active ingredient: 1 branded and 30 generic.

As of Nov 15, 2026, FDA lists 31 applications for Ammonia N-13 (sold as Ammonia N 13), first approved Aug 23, 2007, with 0 new uses approved and 0 published complete response letters.

First approved: Aug 23, 2007
Applications: 31
New uses approved: 0
Complete response letters: 0

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PETSickle Cell Disease · St. Jude Children's Research Hospital	Phase 2	Recruiting	Oct 18, 2022
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary ArteriesMyocardial Infarction, Coronary Microvascular Dysfunction · Chonnam National University Hospital	—	Recruiting	Mar 9, 2022
Safety of PET MPI Using the CRCHUM N-13 AmmoniaN-13 Ammonia Safety · Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4	Recruiting	Sep 7, 2017
Molecular Imaging of Primary Amyloid CardiomyopathyAmyloidosis, Primary, Cardiomyopathy · Brigham and Women's Hospital	Not applicable	Recruiting	Dec 29, 2015
Improvement Assessment of Coronary Flow Dysfunction Using Fundamental Fluid DynamicsCoronary Artery Disease · University of Cincinnati	—	Active, not recruiting	Nov 1, 2012

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Aug 23, 2007	Ammonia N 13NDA 22119 · New molecular entity	Feinstein	1	Marketed
Dec 14, 2012	Ammonia N 13ANDA 203543	Sofie	1	Marketed
Feb 25, 2013	Ammonia N 13ANDA 203321	Mcprf	0	Marketed
Feb 25, 2013	Ammonia N 13ANDA 203700	Cardinal Hlth 414	0	Marketed
Jun 27, 2013	Ammonia N 13ANDA 203812	Ucla Biomedical	0	Marketed
Dec 9, 2013	Ammonia N 13ANDA 203938	Kreitchman Pet Ctr	0	Marketed
Feb 7, 2014	Ammonia N 13ANDA 204506	Wa Univ Sch Med	1	Marketed
Mar 28, 2014	Ammonia N 13ANDA 204496	Ucsf Rodiopharm	0	Marketed
Jun 27, 2014	Ammonia N 13ANDA 203933	Univ Tx Md Anderson	0	Discontinued
Aug 19, 2014	Ammonia N 13ANDA 204514	Johns Hopkins Univ	0	Marketed
Sep 19, 2014	Ammonia N 13ANDA 204366	Shertech Labs LLC	0	Discontinued
Oct 23, 2014	Ammonia N 13ANDA 204465	Sofie	0	Marketed
Oct 30, 2014	Ammonia N 13ANDA 203783	Brigham Womens Hosp	1	Marketed
Nov 20, 2014	Ammonia N 13ANDA 204535	Mips Crf	0	Marketed
Dec 18, 2014	Ammonia N 13ANDA 204356	Wisconsin	0	Discontinued
Feb 4, 2015	Ammonia N 13ANDA 204515	Ncm USA Bronx LLC	0	Marketed
Apr 22, 2015	Ammonia N 13ANDA 204667	Sofie	0	Discontinued
Apr 23, 2015	Ammonia N 13ANDA 204455	Nukemed	0	Discontinued
May 1, 2015	Ammonia N 13ANDA 204352	Biomedcl Res Fdn	0	Marketed
Jun 23, 2015	Ammonia N 13ANDA 204539	Central Radiopharm	0	Discontinued
Aug 14, 2015	Ammonia N 13ANDA 204547	Precision Nuclear	1	Marketed
Oct 19, 2015	Ammonia N 13ANDA 203779	3d Imaging Drug	1	Marketed
Nov 2, 2015	Ammonia N 13ANDA 204510	Petnet	0	Marketed
Nov 18, 2015	Ammonia N 13ANDA 204457	Midwest Medcl	0	Marketed
Dec 17, 2015	Ammonia N 13ANDA 205687	Essential Isotopes	0	Discontinued
Feb 3, 2016	Ammonia N 13ANDA 207025	Gen Hosp	0	Marketed
Dec 21, 2018	Ammonia N 13ANDA 210524	Ionetix	1	Marketed
Nov 1, 2019	Ammonia N 13ANDA 209507	Univ Tx Sw Medctr	0	Marketed
Sep 9, 2020	Ammonia N 13ANDA 211740	Univ Wisconsin	0	Marketed
Jul 9, 2021	Ammonia N 13ANDA 215083	Methodist	0	Marketed
Nov 3, 2022	Ammonia N 13ANDA 211698	Univ Alahama Birm	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA