Amicar

NDA 15230, held by Hikma. Aminocaproic Acid.

As of Nov 13, 2026, NDA 15230 (Amicar), held by Hikma, was first approved by FDA on Jun 4, 1964, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 4, 1964
Review: Priority
Supplements approved: 19
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 20 submissions below

Date	Submission	Status	Documents
Jun 4, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amicar0.25GM/ML · solution;oral	Aminocaproic Acid	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Feb 3, 2009	Supplement 37Labeling · Standard review	Approved	Letter Label
Aug 19, 2008	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 24, 2004	Supplement 31Labeling · Standard review	Approved	Letter
Sep 2, 2003	Supplement 30Manufacturing · Priority review	Approved	Letter
Sep 2, 2003	Supplement 29Manufacturing · Priority review	Approved	Letter
Sep 2, 2003	Supplement 28Manufacturing · Priority review	Approved	Letter
Sep 14, 1999	Supplement 27Manufacturing · Priority review	Approved	None posted
Sep 14, 1999	Supplement 26Manufacturing · Priority review	Approved	None posted
Sep 14, 1999	Supplement 25Manufacturing · Priority review	Approved	None posted
Apr 16, 1997	Supplement 23Labeling · Standard review	Approved	None posted
Jan 17, 1997	Supplement 24Manufacturing · Priority review	Approved	None posted
Apr 3, 1990	Supplement 17Labeling	Approved	None posted
Nov 4, 1986	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 17, 1986	Supplement 21Labeling	Approved	None posted
Jun 6, 1983	Supplement 20Labeling	Approved	None posted
Dec 10, 1982	Supplement 19Labeling	Approved	None posted
Sep 22, 1982	Supplement 18Manufacturing · Priority review	Approved	None posted
Dec 22, 1980	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 17, 1978	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 4, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 15230
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