Magnesium Sulfate In Dextrose 5% In Plastic Container

Prevents eclampsia. NDA 20488, held by Hospira. Magnesium Sulfate.

As of Nov 13, 2026, NDA 20488 (Magnesium Sulfate In Dextrose 5% In Plastic Container), held by Hospira, was first approved by FDA on Jul 11, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 11, 1995
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Magnesium Sulfate in 5% Dextrose Injection is indicated for:

Prevention of eclampsia in patients with preeclampsia
Treatment of seizures and prevention of recurrent seizures in patients with eclampsia

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 11, 1995	Original applicationNew dosage form · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Magnesium Sulfate In Dextrose 5% In Plastic Container1GM/100ML · injectable;injection	Magnesium Sulfate	RxReference drug
Magnesium Sulfate In Dextrose 5% In Plastic Container2GM/100ML · injectable;injection	Magnesium Sulfate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label
Jul 14, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Nov 26, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
May 29, 2013	Supplement 19Labeling · Standard review	Approved	Letter Label
Nov 6, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 28, 1998	Supplement 3Labeling · Standard review	Approved	None posted
Jul 14, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 14, 1997	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 11, 1995	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20488
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