Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 201580, held by Pharmobedient. Tranexamic Acid.

As of Nov 14, 2026, ANDA 201580 (Tranexamic Acid), held by Pharmobedient, was first approved by FDA on Jun 14, 2013, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2013
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
Jun 14, 2013	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 29, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Mar 19, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Oct 19, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jun 25, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jun 14, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 201580
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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