Ringer'S In Plastic Container

NDA 18156, held by B Braun. Calcium Chloride; Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 18156 (Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Aug 6, 1979, with 21 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1979
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ringer’s Irrigation USP 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 22 submissions below

Date	Submission	Status	Documents
Aug 6, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ringer'S In Plastic Container33MG/100ML;30MG/100ML;860MG/100ML · solution;irrigation	Calcium Chloride; Potassium Chloride; Sodium Chloride	Rx

All 22 submissions, including labeling and manufacturing supplements


Feb 13, 2004	Supplement 25Labeling	Approved	None posted
Aug 19, 2002	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 10, 2002	Supplement 23Manufacturing · Standard review	Approved	None posted
May 28, 1998	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 5, 1987	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 17, 1985	Supplement 16Labeling	Approved	None posted
Jun 4, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
May 17, 1985	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Supplement 13Labeling	Approved	None posted
Jan 26, 1985	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 20, 1982	Supplement 9Labeling	Approved	None posted
Nov 6, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 28, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 24, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 16, 1980	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 16, 1980	Supplement 4Labeling	Approved	None posted
Feb 15, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 25, 1979	Supplement 2Labeling	Approved	None posted
Sep 24, 1979	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 6, 1979	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18156
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