Myoview
These highlights do not include all the information needed to use MYOVIEW 30 mL safely and effectively. See full prescribing information for MYOVIEW 30 mL. MYOVIEW 30 mL (Kit for the preparation of technetium Tc99m tetrofosmin injection) for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
98c85037-a907-4a3a-8864-c3a5298b4759
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Medi-Physics Inc. dba GE Healthcare
DUNS: 095263729
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 Code17156-026
Application NumberNDA020372
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tetrofosmin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 12, 2022
FDA Product Classification
INGREDIENTS (4)
Stannous ChlorideInactive
Quantity: 0.09 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
Sodium BicarbonateInactive
Quantity: 11 mg in 1 1
Code: 8MDF5V39QO
Classification: IACT
TetrofosminActive
Quantity: 1.38 mg in 1 1
Code: 3J0KPB596Q
Classification: ACTIB
Ascorbic AcidInactive
Quantity: 3 mg in 1 1
Code: PQ6CK8PD0R
Classification: IACT