Aminosyn Ii 15% In Plastic Container

For adequate stores of body fat. NDA 20041, held by Otsuka Icu Medcl. Amino Acids.

As of Nov 13, 2026, NDA 20041 (Aminosyn Ii 15% In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Dec 19, 1991, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1991
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 19, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminosyn Ii 15% In Plastic Container15% (15GM/100ML) · injectable;injection	Amino Acids	Rx

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2007	Supplement 20Manufacturing	Approved	None posted
Jan 27, 2003	Supplement 13Manufacturing · Standard review	Approved	Letter
Nov 8, 2002	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 21, 2002	Supplement 11Labeling · Standard review	Approved	Letter
May 5, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 6, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 5, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 17, 1992	Supplement 1Labeling	Approved	None posted
Dec 19, 1991	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20041
Drugs@FDA: Overview at FDA
Company: Otsuka 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