Plasma-Lyte 56 In Plastic Container

NDA 19047, held by Baxter Hlthcare. Magnesium Acetate Tetrahydrate; Potassium Acetate; Sodium Chloride.

As of Nov 13, 2026, NDA 19047 (Plasma-Lyte 56 In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Jun 15, 1984, with 19 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1984
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jun 15, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Plasma-Lyte 56 In Plastic Container32MG/100ML;128MG/100ML;234MG/100ML · injectable;injection	Magnesium Acetate Tetrahydrate; Potassium Acetate; Sodium Chloride	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 24, 2005	Supplement 24Manufacturing · Standard review	Approved	Letter Label
Apr 3, 2002	Supplement 18Labeling · Standard review	Approved	Letter
Aug 14, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 1, 2001	Supplement 20Labeling · Standard review	Approved	None posted
Nov 24, 1999	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 29, 1997	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 30, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 10, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 29, 1991	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 15, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 25, 1987	Supplement 7Manufacturing · Standard review	Approved	None posted
May 28, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 27, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 11, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 26, 1985	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 26, 1985	Supplement 2Labeling · Standard review	Approved	None posted
Jun 15, 1984	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19047
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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