Isolyte P In Dextrose 5% In Plastic Container

NDA 19873, held by B Braun. Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate.

As of Nov 13, 2026, NDA 19873 (Isolyte P In Dextrose 5% In Plastic Container), held by B Braun, was first approved by FDA on Jun 10, 1993, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1993
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jun 10, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isolyte P In Dextrose 5% In Plastic Container5GM/100ML;31MG/100ML;130MG/100ML;26MG/100ML;320MG/100ML · injectable;injection	Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate	Rx

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 11, 2004	Supplement 11Labeling	Approved	None posted
Jul 1, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 15, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 7, 2000	Supplement 7Manufacturing · Standard review	Approved	None posted
May 15, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 21, 1998	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 1, 1994	Supplement 1Labeling	Approved	None posted
Jun 10, 1993	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19873
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