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FDA Drug information

Tranexamic Acid

Read time: 1 mins
Marketing start date: 05 Apr 2025
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Summary of product characteristics


Indications And Usage

INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Effective Time

20241028

Version

1

Spl Product Data Elements

Tranexamic Acid Tranexamic Acid TRANEXAMIC ACID TRANEXAMIC ACID WATER

Application Number

ANDA203521

Brand Name

Tranexamic Acid

Generic Name

Tranexamic Acid

Product Ndc

14593-318

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 14593-318-01 Tranexamic Acid Injection, USP 1000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx only 10 mL Single-Dose Vial label

Drug section

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.