Aminosyn Ii 3.5% In Dextrose 25% In Plastic Container, Aminosyn Ii 3.5% In Dextrose 5% In Plastic Container, Aminosyn Ii 4.25% In Dextrose 25% In Plastic Container

NDA 19681, held by Hospira. Amino Acids; Dextrose.

As of Nov 13, 2026, NDA 19681 (Aminosyn Ii 3.5% In Dextrose 25% In Plastic Container, Aminosyn Ii 3.5% In Dextrose 5% In Plastic Container, Aminosyn Ii 4.25% In Dextrose 25% In Plastic Container), held by Hospira, was first approved by FDA on Nov 1, 1988, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1988
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 1, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

6 strengths and forms

Product	Active ingredient	Marketing
Aminosyn Ii 3.5% In Dextrose 25% In Plastic Container3.5%;25GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued
Aminosyn Ii 3.5% In Dextrose 5% In Plastic Container3.5%;5GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued
Aminosyn Ii 4.25% In Dextrose 25% In Plastic Container4.25%;25GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued
Aminosyn Ii 4.25% In Dextrose 10% In Plastic Container4.25%;10GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued
Aminosyn Ii 4.25% In Dextrose 20% In Plastic Container4.25%;20GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued
Aminosyn Ii 5% In Dextrose 25% In Plastic Container5%;25GM/100ML · injectable;injection	Amino Acids; Dextrose	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 19, 2003	Supplement 20Manufacturing · Standard review	Approved	Letter
Nov 8, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
Aug 21, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Aug 21, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Dec 29, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 29, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
May 5, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 30, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 1, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19681
Drugs@FDA: Overview at FDA
Company: Hospira

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