Tranexamic Acid

ANDA 205228, held by Zydus Pharms. Tranexamic Acid.

As of Nov 14, 2026, ANDA 205228 (Tranexamic Acid), held by Zydus Pharms, was first approved by FDA on Jul 17, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 17, 2017
Review: Standard
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
Jul 17, 2017	Original application	Approved	Letter

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


Mar 18, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jun 17, 2022	Supplement 3Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Jul 17, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 205228
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (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