Tetrofosmin
Tetrofosmin (for the preparation of Tc99m Tetrofosmin injection)
Approved
Approval ID
c19c8ed9-24ea-48a2-ad37-3fa3dfd15f06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2012
Manufacturers
FDA
AnazaoHealth Corporation
DUNS: 011038762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tetrofosmin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51808-223
Product Classification
G
Generic Name
Tetrofosmin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 2, 2012
FDA Product Classification
INGREDIENTS (4)
TETROFOSMINActive
Quantity: 0.35 mg in 1 1
Code: 3J0KPB596Q
Classification: ACTIB
DISODIUM SULFOSALICYLATEInactive
Quantity: 0.48 mg in 1 1
Code: WFP6MAA96R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 2.7 mg in 1 1
Code: 8MDF5V39QO
Classification: IACT
GLUCONIC ACIDInactive
Quantity: 1.5 mg in 1 1
Code: R4R8J0Q44B
Classification: IACT