Amicar

NDA 15197, held by Hikma. Aminocaproic Acid.

As of Nov 13, 2026, NDA 15197 (Amicar), held by Hikma, was first approved by FDA on Jun 3, 1964, with 21 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1964
Review: Priority
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products 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 amegakaryocytic thrombocytopenia (accompanying 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 22 submissions below

Date	Submission	Status	Documents
Jun 3, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Amicar500MG · tablet;oral	Aminocaproic Acid	RxReference drug
Amicar1GM · tablet;oral	Aminocaproic Acid	RxReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 19, 2008	Supplement 43Labeling · Standard review	Approved	Label Letter
Aug 24, 2004	Supplement 40Labeling · Standard review	Approved	Letter
Jun 24, 2004	Supplement 39Manufacturing · Priority review	Approved	Letter Label
Jun 24, 2004	Supplement 38Manufacturing · Priority review	Approved	Label Letter
Jun 24, 2004	Supplement 37Manufacturing · Priority review	Approved	Letter Label
Jun 24, 2004	Supplement 36Manufacturing · Priority review	Approved	Letter Label
Nov 27, 2000	Supplement 35Manufacturing · Priority review	Approved	None posted
Oct 2, 2000	Supplement 33Manufacturing · Priority review	Approved	None posted
Apr 3, 2000	Supplement 34Labeling · Standard review	Approved	None posted
Oct 1, 1999	Supplement 32Manufacturing · Priority review	Approved	None posted
Apr 16, 1997	Supplement 30Labeling · Standard review	Approved	None posted
Aug 13, 1992	Supplement 28Manufacturing · Priority review	Approved	None posted
Feb 11, 1992	Supplement 29Manufacturing · Priority review	Approved	None posted
Apr 3, 1990	Supplement 23Labeling	Approved	None posted
Jan 17, 1986	Supplement 27Labeling	Approved	None posted
Jun 6, 1983	Supplement 26Labeling	Approved	None posted
Dec 10, 1982	Supplement 25Labeling	Approved	None posted
Oct 22, 1982	Supplement 22Manufacturing · Priority review	Approved	None posted
Sep 22, 1982	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 30, 1981	Supplement 19Manufacturing · Priority review	Approved	None posted
Feb 9, 1977	Supplement 15Manufacturing · Priority review	Approved	None posted
Jun 3, 1964	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 15197
Drugs@FDA: Overview at FDA
Company: Hikma

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