Cyklokapron

For hemophilia for short-term use (2 to 8 days). NDA 19281, held by Pfizer. Tranexamic Acid.

As of Nov 13, 2026, NDA 19281 (Cyklokapron), held by Pfizer, was first approved by FDA on Dec 30, 1986, with 33 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1986
Review: Standard
Supplements approved: 33
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CYKLOKAPRON is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Dec 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyklokapron100MG/ML · injectable;injection	Tranexamic Acid	RxReference drug

All 34 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 29, 2025	Supplement 48Labeling · Standard review	Approved	Letter Label
Feb 4, 2021	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 7, 2020	Supplement 44Labeling · Standard review	Approved	Label Letter
Nov 21, 2017	Supplement 41Labeling	Approved	Letter Label
Nov 3, 2016	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 1, 2016	Supplement 40Manufacturing · Standard review	Approved	None posted
Feb 1, 2016	Supplement 37Manufacturing · Standard review	Approved	None posted
Oct 20, 2015	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 1, 2015	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 17, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 15, 2014	Supplement 33Manufacturing · Standard review	Approved	Label
May 10, 2013	Supplement 31Labeling · Standard review	Approved	Letter Label
Jan 25, 2011	Supplement 30Labeling · Standard review	Approved	Letter Label
Jan 28, 2009	Supplement 27Labeling · Standard review	Approved	Letter
Dec 22, 2008	Supplement 25Labeling · Standard review	Approved	Label Letter
May 15, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 16, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 2, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 2, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 31, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Jul 31, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 27, 2001	Supplement 13Labeling · Standard review	Approved	Letter
Apr 28, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 15, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 9, 1999	Supplement 9Labeling · Standard review	Approved	Review Letter
Dec 5, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 24, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 7, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 7, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 30, 1986	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19281
Drugs@FDA: Overview at FDA
Company: Pfizer

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