Amicar

NDA 15229, held by Epic Pharma LLC. Aminocaproic Acid.

As of Nov 13, 2026, NDA 15229 (Amicar), held by Epic Pharma LLC, was first approved by FDA on Jun 8, 1964, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1964
Review: Priority
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Dec 5, 1983	Supplement 22Efficacy (new indication or use)	Approved	None posted
Jun 8, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amicar250MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Aminocaproic Acid	DiscontinuedReference drug

All 20 submissions, including labeling and manufacturing supplements


Aug 24, 2004	Supplement 31Labeling · Standard review	Approved	Letter
Apr 3, 2000	Supplement 30Labeling · Standard review	Approved	None posted
Oct 1, 1999	Supplement 29Manufacturing · Priority review	Approved	None posted
Apr 16, 1997	Supplement 28Labeling · Standard review	Approved	None posted
May 19, 1995	Supplement 25Manufacturing · Priority review	Approved	None posted
Mar 7, 1995	Supplement 27Manufacturing · Priority review	Approved	None posted
Nov 1, 1994	Supplement 26Manufacturing · Priority review	Approved	None posted
Apr 3, 1990	Supplement 18Labeling	Approved	None posted
Jan 17, 1986	Supplement 24Labeling	Approved	None posted
Dec 5, 1983	Supplement 22Efficacy (new indication or use)	Approved	None posted
Jun 6, 1983	Supplement 21Labeling	Approved	None posted
Dec 10, 1982	Supplement 20Labeling	Approved	None posted
Sep 22, 1982	Supplement 19Manufacturing · Priority review	Approved	None posted
Oct 10, 1979	Supplement 15Labeling	Approved	None posted
Sep 7, 1979	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 14, 1977	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 14, 1977	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 14, 1977	Supplement 12Manufacturing · Priority review	Approved	None posted
Mar 10, 1977	Supplement 11Manufacturing · Priority review	Approved	None posted
Jun 8, 1964	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 15229
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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