Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 203521, held by Avet Lifesciences. Tranexamic Acid.

As of Nov 14, 2026, ANDA 203521 (Tranexamic Acid), held by Avet Lifesciences, was first approved by FDA on Aug 12, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 12, 2014
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 12, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tranexamic Acid100MG/ML · injectable;injection	Tranexamic Acid	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 28, 2026	Supplement 26Labeling · Standard review	Approved	None posted
Sep 12, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Aug 11, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Jun 28, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Aug 12, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 203521
Drugs@FDA: Overview at FDA
Company: Avet Lifesciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters