Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 202436, held by Heritage. Tranexamic Acid.

As of Nov 15, 2026, ANDA 202436 (Tranexamic Acid), held by Heritage, was first approved by FDA on Feb 11, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 11, 2014
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SECTION 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. Tranexamic acid injection is an antifibrinolytic

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
Feb 11, 2014	Original application	Approved	None posted

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


Sep 16, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Jun 27, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Oct 29, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Sep 13, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Feb 11, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202436
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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