Tranexamic Acid

ANDA 206634, held by Rising. Tranexamic Acid.

As of Nov 14, 2026, ANDA 206634 (Tranexamic Acid), held by Rising, was first approved by FDA on Jun 9, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 9, 2016
Review: Standard
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
Jun 9, 2016	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Jun 14, 2024	Supplement 6Labeling · Standard review	Approved	None posted
May 14, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Jun 9, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206634
Drugs@FDA: Overview at FDA
Company: Rising 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