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Data updated: Mar 10, 2026

MAGNESIUM SULFATE

MAGNESIUM SULFATE
Neurology Approved 1986-09-08
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-09-08
Routes
INTRAMUSCULAR, INTRAVENOUS, INJECTION
Dosage Forms
SOLUTION, INJECTABLE

Companies

ASPIRO Fresenius Kabi Pfizer EXELA PHARMA Baxter B BRAUN MEDICAL
Active Ingredient: MAGNESIUM SULFATE

MAGNESIUM SULFATE Approval History

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What MAGNESIUM SULFATE Treats

6 indications

MAGNESIUM SULFATE is approved for 6 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Magnesium Deficiency
  • Hypomagnesemia
  • Tetany
  • Seizures
  • Pre-Eclampsia
  • Eclampsia
Source: FDA Label

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MAGNESIUM SULFATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

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 (Mg++) level is usually below the lower limit of normal (1.5 to 2.5 mEq/liter) and the serum calcium (Ca++) level is normal (4.3 to 5.3 mEq/liter) 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. Magnesium Sulfate Injecti...

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Data Sources

FDA Approval: ANDA219777 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.