Physiolyte In Plastic Container

NDA 19024, held by B Braun. Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate.

As of Nov 14, 2026, NDA 19024 (Physiolyte In Plastic Container), held by B Braun, was first approved by FDA on Jun 8, 1984, with 13 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1984
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Physiolyte (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jun 8, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Physiolyte In Plastic Container30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML · solution;irrigation	Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate	Rx

All 14 submissions, including labeling and manufacturing supplements


May 8, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 22, 2003	Supplement 15Labeling · Standard review	Approved	Letter
Jul 8, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 3, 2002	Supplement 13Manufacturing · Standard review	Approved	None posted
May 4, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 18, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 25, 1998	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 11, 1990	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 19, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 5, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 18, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 8, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19024
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