Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 91657, held by Mylan Institutional. Tranexamic Acid.

As of Nov 14, 2026, ANDA 91657 (Tranexamic Acid), held by Mylan Institutional, was first approved by FDA on Nov 3, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 3, 2011
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tranexamic acid injection 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
Nov 3, 2011	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


Jun 23, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 9Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Sep 29, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Nov 3, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91657
Drugs@FDA: Overview at FDA
Company: Mylan Institutional

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