LACTATED RINGER'S IN PLASTIC CONTAINERcalcium chloride, potassium chloride, sodium chloride, sodium lactate

FDA approved the original new drug application for LACTATED RINGER'S IN PLASTIC CONTAINER on January 17, 1986, sponsored by OTSUKA ICU MEDCL. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA019416

Sponsor

OTSUKA ICU MEDCL

Original approval

January 17, 1986

Review

standard review

Submission class

Type 5 - New Formulation or New Manufacturer

Active ingredient

calcium chloride, potassium chloride, sodium chloride, sodium lactate

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

Products under this application

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’s record shows no approved efficacy supplement on this application.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 13 · Labeling 1. 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 OTSUKA ICU MEDCL

• November 30, 1992POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERNDA020161
• December 19, 1991AMINOSYN II 15% IN PLASTIC CONTAINERNDA020041
• December 19, 1991AMINOSYN II 10% IN PLASTIC CONTAINERNDA020015
• December 26, 1989STERILE WATER FOR INJECTION IN PLASTIC CONTAINERNDA019869
• December 26, 1989DEXTROSE 70% IN PLASTIC CONTAINERNDA019893
• October 17, 1988POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERNDA019686