Ammonia N 13
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 useInitial U.S. Approval: 2007
Approved
Approval ID
c857724f-b172-4844-ad42-6fa4c42b0405
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2019
Manufacturers
FDA
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
DUNS: 110565913
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NH3N13
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13267-456
Application NumberNDA022119
Product Classification
M
Marketing Category
C73594
G
Generic Name
NH3N13
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 30, 2019
FDA Product Classification
INGREDIENTS (1)
AMMONIA N-13Active
Quantity: 37.5 mCi in 1 mL
Code: 9OQO0E343Z
Classification: ACTIB