Tranexamic Acid

ANDA 201885, held by Am Regent. Tranexamic Acid.

As of Nov 15, 2026, ANDA 201885 (Tranexamic Acid), held by Am Regent, was first approved by FDA on Aug 10, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 10, 2011
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 10, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Jul 20, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Jan 25, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Mar 6, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Dec 21, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 21, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 10, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201885
Drugs@FDA: Overview at FDA
Company: Am Regent

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