DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINERcalcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate

FDA approved the original new drug application for DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER on February 24, 1988, sponsored by B BRAUN. FDA marks 1 of the application’s 3 products discontinued and the other 2 still marketed. FDA’s record shows no approved efficacy supplement on the application since.

Application

NDA019634

Sponsor

B BRAUN

Original approval

February 24, 1988

Review

standard review

Submission class

Type 5 - New Formulation or New Manufacturer

Active ingredient

calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate

Browse every approval whose brand starts with D, or the complete response letters FDA has published — the applications it did not approve.

Products under this application

What “discontinued” means in FDA’s record

Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.

Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 17 · Labeling 5. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

Other approvals to B BRAUN

• June 13, 2011CEFTAZIDIME IN DEXTROSE CONTAINERNDA050823
• May 6, 2010CEFEPIME AND DEXTROSE IN DUPLEX CONTAINERNDA050821
• August 9, 2007CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINERNDA065430
• March 10, 2006CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINERNDA065214
• April 20, 2005CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERNDA050796
• July 29, 2004CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINERNDA050792