Dialyte Concentrate W/ Dextrose 30% In Plastic Container, Dialyte Concentrate W/ Dextrose 50% In Plastic Container

NDA 18807, held by B Braun. Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 18807 (Dialyte Concentrate W/ Dextrose 30% In Plastic Container, Dialyte Concentrate W/ Dextrose 50% In Plastic Container), held by B Braun, was first approved by FDA on Aug 26, 1983, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1983
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Aug 26, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Dialyte Concentrate W/ Dextrose 30% In Plastic Container510MG/100ML;30GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride	Discontinued
Dialyte Concentrate W/ Dextrose 50% In Plastic Container510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride	Discontinued
Dialyte Concentrate W/ Dextrose 30% In Plastic Container510MG/100ML;30GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride	Discontinued
Dialyte Concentrate W/ Dextrose 50% In Plastic Container510MG/100ML;50GM/100ML;200MG/100ML;9.4GM/100ML;11GM/100ML · solution;intraperitoneal	Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 5, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 9, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 19, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 12, 1988	Supplement 7Labeling	Approved	None posted
Mar 5, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 10, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 27, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 3, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 26, 1983	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18807
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