FDA.reportPublic FDA data

AMMONIA N-13 Pharmacologic Class Indexing

Class set ID
9ff70fcc-e565-45b8-98e4-fe226b032507
Version
2
Effective date
20180813
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION safely and effectively. See full prescribing information for AMMONIA N 13 INJECTION. AMMONIA N 13 Injection for intravenous use Initial U.S. Approval: 2007Ionetix Corporation2026041017
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007Kreitchman PET Center202601277
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200X3D Imaging Drug Design and Development LLC202601073
These highlights do not include all the information needed to use Ammonia N 13 Injection USP safely and effectively. See full prescribing information for Ammonia N 13 Injection USP . Ammonia N 13 Injection USP for intravenous use Initial U.S. Approval: 2007Mayo Clinic | Mayo Clinic PET Radiochemistry Facility2025122614
These highlights do not include all the information needed to use Ammonia N 13 Injection, USP safely and effectively. See full prescribing information for Ammonia N 13 Injection, USP. Ammonia N 13 Injection, USP for intravenous use Initial U.S. Approval: 2007Biomedical Research Foundation of Northwest Louisiana202512148
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007PETNET Solutions, Inc.202512035
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use. Ammonia N13 Injection Initial U.S. Approval: 2007UCSF Radiopharmaceutical Facility2025111412
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION for intravenous use safely and effectively. See full prescribing information for AMMONIA N 13 INJECTION. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007University of Alabama at Birmingham | UAB Radiopharmaceutical PET Facility202510157
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION safely and effectively. See full prescribing information for AMMONIA N 13 INJECTION. AMMONIA N 13 INJECTION, for intravenous use Initial U.S. Approval: 2007University of Wisconsin System | UW Radiopharmaceutical Production Facility2025101413
These highlights do not include all the information needed to use Ammonia N 13 Injection USP safely and effectively. See full prescribing information for Ammonia N 13 Injection USP. Ammonia N 13 Injection USP for intravenous use Initial U.S. Approval: 2007The Johns Hopkins University | The Johns Hopkins University PET Center2025101414
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007SOFIE Co. dba SOFIE202504033
These highlights do not include all the information needed to use Ammonia N13 Injection safely and effectively. See full prescribing information for Ammonia N13 Injection . Ammonia N13 Injection, USP for intravenous use Initial U.S. Approval: 2007SOFIE Co. dba SOFIE202504013
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION safely and effectively. See full prescribing information for AMMONIA N 13 INJECTION. AMMONIA N 13 INJECTION USP for Intravenous Use Initial U.S. Approval: 2007Precision Nuclear LLC | Precision Nuclear of Virginia LLC | PharmaLogic Colorado, LLC | Wisconsin Medical Radiopharmacy, LLC | Essential Isotopes, LLC | Hot Shots Nm, LLC2024121111
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2021The Methodist Hospital Research Institute202312192
These highlights do not include all the information needed to use AMMONIA N 13 INJECTION safely and effectively. See full prescribing information for AMMONIA N 13 INJECTION. AMMONIA N 13 INJECTION for intravenous use Initial U.S. Approval: 2007The University of Texas Southwestern Medical Center202211176
These highlights do not include all the information needed to use AMMONIA N13 INJECTION safely and effectively. See full prescribing information for AMMONIA N13 INJECTION. AMMONIA N13 INJECTION for intravenous use Initial U.S. Approval: 2007Massachusetts General Hospital | Massachusetts General Hospital PET Center202111255
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007Brigham and Women's Hospital, Inc., The | Brigham and Women's Hospital, Inc202111037
These highlights do not include all the information needed to use Ammonia N 13 Injection USP safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection USP for intravenous use Initial U.S. Approval: 2007Washington University School of Medicine | Washington University School of Medicine Cyclotron Facility202110299
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 2007THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH2019103020191030
These highlights do not include all the information needed to use Ammonia N-13 Injection, USP safely and effectively. See full prescribing information for Ammonia N-13 Injection, USP. Ammonia N-13 Injection, USP for intravenous use Initial U.S. Approval: 2007Cardinal Health 414, LLC201807117
These highlights do not include all the information needed to use Ammonia N 13 Injection safely and effectively. See full prescribing information for Ammonia N 13 Injection. Ammonia N 13 Injection for intravenous use Initial U.S. Approval: 200XChildren's Hospital of Michigan201110241