Dextrose 5% In Lactated Ringer'S In Plastic Container

NDA 17510, held by B Braun. Calcium Chloride; Dextrose; Potassium Chloride; Sodium Chloride; Sodium Lactate.

As of Nov 13, 2026, NDA 17510 (Dextrose 5% In Lactated Ringer'S In Plastic Container), held by B Braun, was first approved by FDA on Feb 8, 1978, with 22 approved supplements and 0 published complete response letters.

First approved: Feb 8, 1978
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 8, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
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	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Sep 11, 1990	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 18, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 22, 1985	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 25, 1985	Supplement 23Labeling · Standard review	Approved	None posted
May 17, 1985	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 15, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 24, 1983	Supplement 14Labeling · Standard review	Approved	None posted
Oct 26, 1981	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 24, 1980	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 26, 1980	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 6, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 16, 1980	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 12, 1980	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 16, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 9, 1979	Supplement 8Labeling · Standard review	Approved	None posted
Jun 8, 1979	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 4, 1979	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 29, 1978	Supplement 2Labeling · Standard review	Approved	None posted
Sep 29, 1978	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 26, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Mar 23, 1978	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 8, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17510
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