Tranexamic Acid

ANDA 202373, held by Epic Pharma LLC. Tranexamic Acid.

As of Nov 15, 2026, ANDA 202373 (Tranexamic Acid), held by Epic Pharma LLC, was first approved by FDA on Nov 17, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 17, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Nov 9, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Feb 19, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Nov 17, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 202373
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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