Magnesium Sulfate In Plastic Container

Controls seizures in pre-eclampsia and eclampsia, respectively. NDA 20309, held by Hospira. Magnesium Sulfate.

As of Nov 13, 2026, NDA 20309 (Magnesium Sulfate In Plastic Container), held by Hospira, was first approved by FDA on Jun 24, 1994, with 15 approved supplements and 0 published complete response letters.

First approved: Jun 24, 1994
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jun 24, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Products

5 strengths and forms


Magnesium Sulfate In Plastic Container4GM/100ML (40MG/ML) · injectable;injection	Magnesium Sulfate	RxReference drug
Magnesium Sulfate In Plastic Container4GM/50ML (80MG/ML) · injectable;injection	Magnesium Sulfate	DiscontinuedReference drug
Magnesium Sulfate In Plastic Container2GM/50ML (40MG/ML) · injectable;injection	Magnesium Sulfate	RxReference drug
Magnesium Sulfate In Plastic Container20GM/500ML (40MG/ML) · injectable;injection	Magnesium Sulfate	RxReference drug
Magnesium Sulfate In Plastic Container40GM/1000ML (40MG/ML) · injectable;injection	Magnesium Sulfate	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Jul 28, 2022	Supplement 32Manufacturing	Approved	Label Letter
Nov 26, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Nov 7, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
May 29, 2013	Supplement 28Labeling · Standard review	Approved	Label Letter
Jan 26, 2007	Supplement 15Manufacturing	Approved	Letter
Nov 6, 2002	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 28, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Oct 22, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 14, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 21, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Aug 29, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 27, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 28, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 23, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Jan 18, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 24, 1994	Original applicationNew formulation or manufacturer · Standard review	Approved	Review

Identifiers

Application: NDA 20309
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