Sodium Chloride 0.9% In Plastic Thermoject Kit For Cardiac Output Use, Sodium Chloride 0.9% In Plastic Container

NDA 19217, held by Icu Medical Inc. Sodium Chloride.

As of Nov 13, 2026, NDA 19217 (Sodium Chloride 0.9% In Plastic Thermoject Kit For Cardiac Output Use, Sodium Chloride 0.9% In Plastic Container), held by Icu Medical Inc, was first approved by FDA on Jul 13, 1984, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1984
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 13, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Sodium Chloride 0.9% In Plastic Thermoject Kit For Cardiac Output Use90MG/10ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 0.9% In Plastic Container45MG/5ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 0.9% In Plastic Container90MG/10ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug
Sodium Chloride 0.9% In Plastic Container360MG/40ML (9MG/ML) · solution;injection	Sodium Chloride	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 5, 2003	Supplement 3Labeling · Standard review	Approved	Letter
Apr 1, 1999	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 22, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 18, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 25, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 13, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19217
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