Aminosyn Ii 3.5% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container, Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 20% W/ Calcium In Plastic Container, Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container

NDA 19683, held by Hospira Inc. Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride.

As of Nov 13, 2026, NDA 19683 (Aminosyn Ii 3.5% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container, Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 20% W/ Calcium In Plastic Container, Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container), held by Hospira Inc, was first approved by FDA on Nov 7, 1988, with 20 approved supplements and 0 published complete response letters.

First approved: Nov 7, 1988
Review: Standard
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Nov 7, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Aminosyn Ii 3.5% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 20% W/ Calcium In Plastic Container4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 4.25% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 5% W/ Electrolytes In Dextrose 25% W/ Calcium In Plastic Container5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML · injectable;injection	Amino Acids; Calcium Chloride; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 5, 2005	Supplement 27Labeling · Standard review	Approved	Letter Label
May 19, 2003	Supplement 19Labeling · Standard review	Approved	None posted
Jan 31, 2003	Supplement 21Manufacturing · Standard review	Approved	Letter
Nov 8, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 29, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 29, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 20, 1997	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 14Manufacturing · Standard review	Approved	None posted
May 5, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 4, 1996	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 18, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 11, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 30, 1993	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 28, 1992	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 30, 1991	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 7, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19683
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