Plegisol In Plastic Container

NDA 18608, held by Hospira. Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride.

As of Nov 13, 2026, NDA 18608 (Plegisol In Plastic Container), held by Hospira, was first approved by FDA on Feb 26, 1982, with 28 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1982
Review: Priority
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Feb 26, 1982	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Plegisol In Plastic Container17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML · solution;perfusion, cardiac	Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Chloride	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Dec 16, 2002	Supplement 31Labeling · Standard review	Approved	Letter
Dec 12, 2000	Supplement 35Manufacturing · Priority review	Approved	None posted
Oct 18, 1999	Supplement 34Labeling · Standard review	Approved	None posted
Nov 14, 1997	Supplement 33Manufacturing · Priority review	Approved	None posted
Sep 5, 1997	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 20, 1997	Supplement 30Manufacturing · Priority review	Approved	None posted
Mar 20, 1997	Supplement 29Manufacturing · Priority review	Approved	None posted
Jan 28, 1992	Supplement 26Manufacturing · Priority review	Approved	None posted
Sep 10, 1991	Supplement 25Manufacturing · Priority review	Approved	None posted
Feb 22, 1990	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 11, 1990	Supplement 23Manufacturing · Priority review	Approved	None posted
Sep 13, 1989	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 9, 1987	Supplement 10Labeling	Approved	None posted
Mar 9, 1987	Supplement 5Manufacturing · Priority review	Approved	None posted
Nov 26, 1986	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 8, 1986	Supplement 18Manufacturing · Priority review	Approved	None posted
Jan 31, 1986	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 31, 1986	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 29, 1985	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 26, 1985	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 9, 1984	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 22, 1984	Supplement 14Manufacturing · Priority review	Approved	None posted
Oct 17, 1984	Supplement 8Manufacturing · Priority review	Approved	None posted
Mar 21, 1984	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 1, 1984	Supplement 3Manufacturing · Priority review	Approved	None posted
Oct 21, 1982	Supplement 1Labeling	Approved	None posted
Jul 26, 1982	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 18, 1982	Supplement 2Manufacturing · Priority review	Approved	None posted
Feb 26, 1982	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18608
Drugs@FDA: Overview at FDA
Company: Hospira

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