Aminocaproic Acid In Plastic Container

ANDA 70010, held by Hospira. Aminocaproic Acid.

As of Nov 15, 2026, ANDA 70010 (Aminocaproic Acid In Plastic Container), held by Hospira, was first approved by FDA on Mar 9, 1987, with 13 approved supplements and 0 published complete response letters.

First approved: Mar 9, 1987
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Aminocaproic Acid Injection, is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Mar 9, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminocaproic Acid In Plastic Container250MG/ML · injectable;injection	Aminocaproic Acid	Rx

All 14 submissions, including labeling and manufacturing supplements


Feb 27, 2007	Supplement 16Labeling	Approved	None posted
Nov 15, 2002	Supplement 13Labeling	Approved	None posted
Feb 15, 2001	Supplement 12Manufacturing	Approved	None posted
Oct 20, 1999	Supplement 10Labeling	Approved	None posted
Oct 20, 1999	Supplement 9Manufacturing	Approved	None posted
Jun 8, 1999	Supplement 11Labeling	Approved	None posted
Sep 8, 1998	Supplement 8Labeling	Approved	None posted
Oct 22, 1996	Supplement 6Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 7Manufacturing	Approved	None posted
Jan 26, 1995	Supplement 4Manufacturing	Approved	None posted
Jul 27, 1994	Supplement 3Manufacturing	Approved	None posted
May 21, 1993	Supplement 2Labeling	Approved	None posted
Dec 3, 1991	Supplement 1Labeling	Approved	None posted
Mar 9, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70010
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