FDA.reportPublic FDA data

AMMONIA N-13 - Food and Drug Administration

Set ID
b8eb56be-edf0-4b39-8ab1-e48c4aa676ef
Type
Indexing - product concept
Effective date
2022-01-26
Version
5
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
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: 2007Product nameIonetix Corporation2026-10-12
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: 2007Product nameWashington University School of Medicine | Washington University School of Medicine Cyclotron Facility2026-10-09
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: 2007Product nameThe Johns Hopkins University | The Johns Hopkins University PET Center2026-10-02
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: 2007Product nameBiomedical Research Foundation of Northwest Louisiana2026-06-10
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: 2007Product nameIonetix Corporation2026-04-10
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: 2007Product nameKreitchman PET Center2026-01-27
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: 200XProduct name3D Imaging Drug Design and Development LLC2026-01-07
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: 2007Product nameMayo Clinic | Mayo Clinic PET Radiochemistry Facility2025-12-26
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: 2007Product nameBiomedical Research Foundation of Northwest Louisiana2025-12-14
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: 2007Product namePETNET Solutions, Inc.2025-12-03
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: 2007Product nameUCSF Radiopharmaceutical Facility2025-11-14
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: 2007Product nameUniversity of Alabama at Birmingham | UAB Radiopharmaceutical PET Facility2025-10-15
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: 2007Product nameUniversity of Wisconsin System | UW Radiopharmaceutical Production Facility2025-10-14
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: 2007Product nameThe Johns Hopkins University | The Johns Hopkins University PET Center2025-10-14
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: 2007Product nameSOFIE Co. dba SOFIE2025-04-03
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: 2007Product nameSOFIE Co. dba SOFIE2025-04-01
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: 2007Product namePrecision Nuclear LLC | Precision Nuclear of Virginia LLC | PharmaLogic Colorado, LLC | Wisconsin Medical Radiopharmacy, LLC | Essential Isotopes, LLC | Hot Shots Nm, LLC2024-12-11
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: 2007Product nameUniversity of Alabama at Birmingham | UAB Radiopharmaceutical PET Facility2024-10-21
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: 2007Product nameUniversity of Wisconsin System | UW Radiopharmaceutical Production Facility2024-10-21
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: 2007Product nameThe Johns Hopkins University | The Johns Hopkins University PET Center2024-10-21
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: 2021Product nameThe Methodist Hospital Research Institute2023-12-19
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: 2007Product nameThe University of Texas Southwestern Medical Center2022-11-17
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: 2007Product nameMassachusetts General Hospital | Massachusetts General Hospital PET Center2021-11-25
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: 2007Product nameBrigham and Women's Hospital, Inc., The | Brigham and Women's Hospital, Inc2021-11-03
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: 2007Product nameWashington University School of Medicine | Washington University School of Medicine Cyclotron Facility2021-10-29
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: 2007Product nameTHE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH2019-10-30
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: 2007Product nameCardinal Health 414, LLC2018-07-11
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: 200XProduct nameChildren's Hospital of Michigan2011-10-24