Aminosyn-Rf 5.2%

NDA 18429, held by Icu Medical Inc. Amino Acids.

As of Nov 13, 2026, NDA 18429 (Aminosyn-Rf 5.2%), held by Icu Medical Inc, was first approved by FDA on Nov 28, 1980, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 28, 1980
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 28, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminosyn-Rf 5.2%5.2% (5.2GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Jun 18, 2003	Supplement 21Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 19Manufacturing · Standard review	Approved	Letter
Aug 27, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 10, 1992	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 19, 1987	Supplement 14Labeling	Approved	None posted
Jan 31, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 11, 1985	Supplement 10Labeling	Approved	None posted
Oct 26, 1985	Supplement 9Manufacturing · Standard review	Approved	None posted
May 8, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 13, 1983	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 5, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 1983	Supplement 4Labeling	Approved	None posted
Jan 21, 1983	Supplement 2Labeling	Approved	None posted
Jan 19, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 20, 1981	Supplement 1Labeling	Approved	None posted
Nov 28, 1980	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18429
Drugs@FDA: Overview at FDA
Company: ICU Medical

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