Aminocaproic Acid

NDA 18590, held by Baxter Hlthcare. Aminocaproic Acid.

As of Nov 14, 2026, NDA 18590 (Aminocaproic Acid), held by Baxter Hlthcare, was first approved by FDA on Oct 29, 1982, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1982
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 29, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminocaproic Acid250MG/ML · injectable;injection	Aminocaproic Acid	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 9, 1999	Supplement 17Labeling	Approved	None posted
Oct 22, 1998	Supplement 16Manufacturing	Approved	None posted
Sep 16, 1997	Supplement 15Manufacturing	Approved	None posted
Jul 6, 1992	Supplement 13Labeling	Approved	None posted
May 19, 1992	Supplement 14Manufacturing	Approved	None posted
Sep 25, 1987	Supplement 9Manufacturing	Approved	None posted
Nov 3, 1986	Supplement 11Manufacturing	Approved	None posted
Oct 29, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18590
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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