MedPath
FDA Product

Myoview

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Myoview

17156-024

Regulatory Information

17156-024

NDA020372

C73594

December 12, 2022

USA

These highlights do not include all the information needed to use MYOVIEW safely and effectively. See full prescribing information for MYOVIEW. MYOVIEW (Kit for the preparation of technetium Tc99m tetrofosmin injection) for intravenous use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

095263729

Active Ingredients

Stannous Chloride

Quantity: 0.03 mg in 1 1

Code: 1BQV3749L5

Class Code: IACT

Disodium Sulfosalicylate

Quantity: 0.32 mg in 1 1

Code: WFP6MAA96R

Class Code: IACT

Tetrofosmin

Quantity: 0.23 mg in 1 1

Code: 3J0KPB596Q

Class Code: ACTIB

Sodium Bicarbonate

Quantity: 1.8 mg in 1 1

Code: 8MDF5V39QO

Class Code: IACT

Active Moieties

Tetrofosmin

Code: 3J0KPB596Q

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