AMINOSYN 10% (PH6)amino acids, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, potassium phosphate, dibasic

FDA approved the original new drug application for AMINOSYN 10% (PH6) on December 3, 1975, sponsored by ICU MEDICAL INC. FDA marks all 9 products under the application discontinued. FDA has approved 1 efficacy supplement on the application since, the most recent on August 27, 1976.

Application

NDA017673

Sponsor

ICU MEDICAL INC

Original approval

December 3, 1975

Review

standard review

Submission class

Type 3 - New Dosage Form

Active ingredient

amino acids, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, potassium phosphate, dibasic

Browse every approval whose brand starts with A, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 45 · Labeling 21. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to ICU MEDICAL INC

• October 30, 1992MORPHINE SULFATENDA019917
• October 30, 1992MORPHINE SULFATENDA019916
• December 26, 1989DEXTROSE 50% IN PLASTIC CONTAINERNDA019894
• April 3, 1986AMINOSYN II 8.5% W/ELECTROLYTESNDA019437
• April 3, 1986AMINOSYN II 10%NDA019438
• January 17, 1986POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERNDA018876