Magnesium Sulfate

Controls seizures in a pre-eclampsia and eclampsia, respectively. NDA 19316, held by Fresenius Kabi USA. Magnesium Sulfate.

As of Nov 13, 2026, NDA 19316 (Magnesium Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Sep 8, 1986, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 8, 1986
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: Magnesium Sulfate Injection, USP is suitable for replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. In such cases, the serum magnesium level is usually below the lower limit of normal (1.5 to 2.5 mEq/L) and the serum calcium level is normal (4.3 to 5.3 mEq/L) or elevated. In total parenteral nutrition (TPN), magnesium sulfate may be added to the nutrient admixture to correct or prevent hypomagnesemia which can arise during the course of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 8, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


Magnesium Sulfate5GM/10ML (500MG/ML) · solution;intramuscular, intravenous	Magnesium Sulfate	RxReference drug
Magnesium Sulfate1GM/2ML (500MG/ML) · solution;intramuscular, intravenous	Magnesium Sulfate	RxReference drug
Magnesium Sulfate10GM/20ML (500MG/ML) · solution;intramuscular, intravenous	Magnesium Sulfate	RxReference drug
Magnesium Sulfate25GM/50ML (500MG/ML) · solution;intramuscular, intravenous	Magnesium Sulfate	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


Mar 5, 2018	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 29, 2016	Supplement 20Manufacturing · Standard review	Approved	None posted
Jan 29, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 19, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
May 29, 2013	Supplement 18Labeling	Approved	Label Letter
Dec 5, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 1, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 28, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Feb 7, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 28, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Dec 12, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 16, 1991	Supplement 3Labeling	Approved	None posted
Nov 13, 1987	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 19, 1987	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 8, 1986	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19316
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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