Aminosyn Ii 10% W/ Electrolytes, Aminosyn Ii 8.5% W/ Electrolytes, Aminosyn Ii 7% W/ Electrolytes

NDA 19437, held by Icu Medical Inc. Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride, Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate, Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic.

As of Nov 13, 2026, NDA 19437 (Aminosyn Ii 10% W/ Electrolytes, Aminosyn Ii 8.5% W/ Electrolytes, Aminosyn Ii 7% W/ Electrolytes), held by Icu Medical Inc, was first approved by FDA on Apr 3, 1986, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 3, 1986
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Apr 3, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms


Aminosyn Ii 10% W/ Electrolytes10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 8.5% W/ Electrolytes8.5%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 7% W/ Electrolytes7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride	Discontinued
Aminosyn Ii 3.5% M3.5%;30MG/100ML;97MG/100ML;120MG/100ML;49MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate	Discontinued
Aminosyn Ii 8.5% W/Electrolytes8.5%;102MG/100ML;492MG/100ML;60MG/100ML;425MG/100ML · injectable;injection	Amino Acids; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jun 6, 2016	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 31, 2013	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 23, 2003	Supplement 14Labeling · Standard review	Approved	Letter
Oct 25, 2002	Supplement 15Manufacturing · Standard review	Approved	Letter
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
Sep 28, 1992	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 18, 1992	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 10, 1992	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 17, 1988	Supplement 5Labeling	Approved	None posted
Dec 1, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 4, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 4, 1986	Supplement 2Labeling	Approved	None posted
Apr 3, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19437
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