Overview
Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3 with a molecular weight of 16.02. Ammonia N 13 Injection, USP is used for imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Indication
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.
Associated Conditions
- Coronary Artery Disease (CAD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mayo Clinic | 52670-552 | INTRAVENOUS | 37.5 mCi in 1 mL | 12/4/2023 | |
| The Methodist Hospital Research Institute | 69864-002 | INTRAVENOUS | 260 mCi in 1 mL | 12/19/2023 | |
| Biomedical Research Foundation of Northwest Louisiana | 24562-004 | INTRAVENOUS | 37.5 mCi in 1 mL | 5/12/2015 | |
| University of Alabama at Birmingham | 69714-001 | INTRAVENOUS | 37.5 mCi in 1 mL | 6/12/2019 | |
| Kreitchman PET Center | 62072-456 | INTRAVENOUS | 37.5 mCi in 1 mL | 1/17/2020 | |
| The Johns Hopkins University | 40089-113 | INTRAVENOUS | 37.5 mCi in 1 mL | 10/16/2019 | |
| Precision Nuclear LLC | 52768-100 | INTRAVENOUS | 260 mCi in 1 mL | 5/31/2022 | |
| PETNET Solutions, Inc. | 40028-513 | INTRAVENOUS | 37.5 mCi in 1 mL | 12/6/2023 | |
| Massachusetts General Hospital | 76318-643 | INTRAVENOUS | 37.5 mCi in 1 mL | 10/24/2019 | |
| SOFIE Co. | 49609-201 | INTRAVENOUS | 37.5 mCi in 1 mL | 5/8/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.