Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 206713, held by Micro Labs. Tranexamic Acid.

As of Nov 15, 2026, ANDA 206713 (Tranexamic Acid), held by Micro Labs, was first approved by FDA on Jun 27, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2017
Review: Standard
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Jun 27, 2017	Original application	Approved	Letter

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Aug 31, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Jul 2, 2026	Supplement 6Labeling · Standard review	Approved	None posted
Jun 24, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Nov 18, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Apr 26, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Jun 27, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 206713
Drugs@FDA: Overview at FDA
Company: Micro Labs Limited

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