Aminosyn-Hf 8%

ANDA 20345, held by Icu Medical Inc. Amino Acids.

As of Nov 15, 2026, ANDA 20345 (Aminosyn-Hf 8%), held by Icu Medical Inc, was first approved by FDA on Apr 4, 1996, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 4, 1996
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 4, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminosyn-Hf 8%8% (8GM/100ML) · injectable;injection	Amino Acids	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Sep 15, 2005	Supplement 8Labeling	Approved	None posted
Apr 1, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 14, 1997	Supplement 1Labeling	Approved	None posted
Apr 4, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: ANDA 20345
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