Lactated Ringer'S In Plastic Container

NDA 19416, held by Otsuka Icu Medcl. Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 19416 (Lactated Ringer'S In Plastic Container), held by Otsuka Icu Medcl, was first approved by FDA on Jan 17, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 17, 1986
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 17, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lactated Ringer'S In Plastic Container20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML · solution;irrigation	Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Aug 15, 2014	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 15Labeling	Approved	None posted
Aug 21, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 11, 1997	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 28, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 10, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 22, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 11, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 22, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 14, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 26, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 8, 1986	Supplement 2Manufacturing · Standard review	Approved	None posted
May 13, 1986	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 17, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19416
Drugs@FDA: Overview at FDA
Company: Otsuka 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