Aminocaproic Acid

ANDA 70888, held by Hospira. Aminocaproic Acid.

As of Nov 15, 2026, ANDA 70888 (Aminocaproic Acid), held by Hospira, was first approved by FDA on Jun 16, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 16, 1988
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
Jun 16, 1988	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


May 10, 1995	Supplement 10Manufacturing	Approved	None posted
Jan 6, 1994	Supplement 9Labeling	Approved	None posted
Oct 30, 1992	Supplement 8Manufacturing	Approved	None posted
Feb 24, 1992	Supplement 6Labeling	Approved	None posted
Jun 17, 1991	Supplement 3Manufacturing	Approved	None posted
Jun 17, 1991	Supplement 4Manufacturing	Approved	None posted
Jun 17, 1991	Supplement 5Manufacturing	Approved	None posted
Jun 16, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 70888
Drugs@FDA: Overview at FDA
Company: Hospira

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