Tranexamic Acid

ANDA 91596, held by Fresenius Kabi USA. Tranexamic Acid.

As of Nov 15, 2026, ANDA 91596 (Tranexamic Acid), held by Fresenius Kabi USA, was first approved by FDA on Mar 2, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 2, 2012
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 2, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jun 24, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Aug 14, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Feb 19, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 2, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91596
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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