Dextrose 2.5% In Half-Strength Lactated Ringer'S In Plastic Container, Dextrose 4% In Modified Lactated Ringer'S In Plastic Container, Dextrose 5% In Lactated Ringer'S In Plastic Container

NDA 19634, held by B Braun. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 14, 2026, NDA 19634 (Dextrose 2.5% In Half-Strength Lactated Ringer'S In Plastic Container, Dextrose 4% In Modified Lactated Ringer'S In Plastic Container, Dextrose 5% In Lactated Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Feb 24, 1988, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 24, 1988
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Feb 24, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Dextrose 2.5% In Half-Strength Lactated Ringer'S In Plastic Container10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx
Dextrose 4% In Modified Lactated Ringer'S In Plastic Container4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Discontinued
Dextrose 5% In Lactated Ringer'S In Plastic Container20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML · injectable;injection	Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate	Rx

All 23 submissions, including labeling and manufacturing supplements


Nov 5, 2025	Supplement 58Labeling · Standard review	Approved	Letter Label
Nov 3, 2021	Supplement 50Labeling · Standard review	Approved	Label Letter
Aug 22, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 13, 2013	Supplement 33Labeling · Standard review	Approved	Letter Label
Sep 27, 2004	Supplement 21Labeling · Standard review	Approved	Label Letter
Jul 23, 2002	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 8, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 12, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 11, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
May 4, 1999	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 25, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 21, 1993	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 26, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 29, 1992	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 29, 1991	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 18, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 13, 1990	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 21, 1989	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 5Manufacturing · Standard review	Approved	None posted
May 5, 1989	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 21, 1988	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 25, 1988	Supplement 1Labeling	Approved	None posted
Feb 24, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19634
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