Lactated Ringer'S In Plastic Container

NDA 18921, held by Baxter Hlthcare. Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 18921 (Lactated Ringer'S In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Apr 3, 1984, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 3, 1984
Review: Standard
Supplements approved: 20
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 use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 3, 1984	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 21 submissions, including labeling and manufacturing supplements


Sep 29, 2015	Supplement 31Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 29, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 21Manufacturing · Standard review	Approved	None posted
May 26, 1999	Supplement 20Labeling	Approved	None posted
Apr 29, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 8, 1993	Supplement 15Manufacturing · Standard review	Approved	None posted
May 8, 1991	Supplement 13Labeling	Approved	None posted
Mar 26, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 22, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Jan 12, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 13, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 26, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 3, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18921
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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