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FDA Product

Tranexamic Acid

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

Basic Information

Tranexamic Acid

67457-197

Regulatory Information

67457-197

ANDA091657

C73584

November 16, 2016

USA

These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION. TRANEXAMIC ACID injection, for intravenous useInitial U.S. Approval: 1986

HUMAN PRESCRIPTION DRUG LABEL

20

Company Information

790384502

Active Ingredients

WATER

Code: 059QF0KO0R

Class Code: IACT

TRANEXAMIC ACID

Quantity: 100 mg in 1 mL

Code: 6T84R30KC1

Class Code: ACTIB

Active Moieties

TRANEXAMIC ACID

Code: 6T84R30KC1

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