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FDA Drug information

Tranexamic Acid

Read time: 1 mins
Marketing start date: 29 Apr 2024
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Summary of product characteristics


Effective Time

20221105

Version

5

Spl Product Data Elements

Tranexamic Acid Tranexamic Acid TRANEXAMIC ACID TRANEXAMIC ACID WATER

Application Number

ANDA205228

Brand Name

Tranexamic Acid

Generic Name

Tranexamic Acid

Product Ndc

70771-1085

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL CONTAINER LABEL NDC 70771-1085-1 Tranexamic Acid Injection 1000 mg/10 mL (100 mg/mL) Solution for Intravenous Injection Discard any remaining portion after single use. 10 mL Single-Dose Vial Rx only zydus pharmaceuticals CARTON LABEL NDC 70771-1085-6 Tranexamic Acid Injection 1000 mg/10 mL (100 mg/mL) Solution for Intravenous Injection Discard any remaining portion after single use. 10 X 10 mL Single-Dose Vials Rx only zydus pharmaceuticals figure02 figure03

Drug section

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