Aminosyn-Hbc 7%

NDA 19374, held by Icu Medical Inc. Amino Acids.

As of Nov 13, 2026, NDA 19374 (Aminosyn-Hbc 7%), held by Icu Medical Inc, was first approved by FDA on Jul 12, 1985, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 12, 1985
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 12, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminosyn-Hbc 7%7% (7GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 25, 2002	Supplement 15Manufacturing · Standard review	Approved	Letter
Nov 3, 1999	Supplement 14Labeling · Standard review	Approved	None posted
Jan 22, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
May 5, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 30, 1993	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 10, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 21, 1987	Supplement 6Labeling	Approved	None posted
Apr 1, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 31, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 12, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 12, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 12, 1985	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19374
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