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FDA Product

Tranexamic Acid

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

Basic Information

Tranexamic Acid

70860-407

Regulatory Information

70860-407

ANDA203521

C73584

December 22, 2023

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 use Initial U.S. Approval: 1986

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

080318964

Active Ingredients

tranexamic acid

Quantity: 100 mg in 1 mL

Code: 6T84R30KC1

Class Code: ACTIB

water

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

tranexamic acid

Code: 6T84R30KC1

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