Tranexamic Acid

For hemophilia for short-term use (2 to 8 days). ANDA 208840, held by Amneal Pharms Co. Tranexamic Acid.

As of Nov 15, 2026, ANDA 208840 (Tranexamic Acid), held by Amneal Pharms Co, was first approved by FDA on Feb 28, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2017
Review: Standard
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Feb 28, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jun 24, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Jun 24, 2021	Supplement 4Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Feb 28, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208840
Drugs@FDA: Overview at FDA
Company: Amneal 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