Technetium Tc 99m Mertiatide

FDA Drug Profile — TECHNETIUM Tc 99m MERTIATIDE

Drug Details

Generic Name
Technetium Tc 99m Mertiatide
Brand Names
TECHNETIUM Tc 99m MERTIATIDE
Application Number
NDA216820
Sponsor
Jubilant DraxImage Inc., dba Jubilant Radiopharma
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
BETIATIDE

Indications and Usage

1 INDICATIONS AND USAGE Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. Kit for the Preparation of Technetium Tc 99m Mertiatide Injection, after radiolabeling with technetium-99m, is a radioactive diagnostic agent indicated for use in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older. The product is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. ( 1 )