Lactated Ringer'S In Plastic Container

NDA 18681, held by B Braun. Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 14, 2026, NDA 18681 (Lactated Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Dec 27, 1982, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 27, 1982
Review: Standard
Supplements approved: 15
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 16 submissions below

Date	Submission	Status	Documents
Dec 27, 1982	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 16 submissions, including labeling and manufacturing supplements


Sep 2, 2014	Supplement 27Manufacturing	Approved	Label
May 31, 2007	Supplement 19Labeling	Approved	None posted
Aug 21, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 25, 1998	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 4, 1995	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 19, 1988	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 5, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 13, 1985	Supplement 8Labeling	Approved	None posted
Jul 16, 1985	Supplement 7Labeling	Approved	None posted
Apr 3, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 18, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 18, 1985	Supplement 3Labeling	Approved	None posted
Jan 19, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 27, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18681
Drugs@FDA: Overview at FDA
Company: B. Braun 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