Controls seizures (convulsions) in pre-eclampsia and eclampsia, respectively. ANDA 75151, held by Hospira. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 75151 (Magnesium Sulfate), held by Hospira, was first approved by FDA on Apr 25, 2000, with 4 approved supplements and 0 published complete response letters.
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 (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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Magnesium Sulfate5GM/10ML (500MG/ML) · solution;intramuscular, intravenous | Magnesium Sulfate | Rx |
| Nov 26, 2019 | Supplement 15Labeling · Standard review | Approved | None posted |
| Oct 26, 2015 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 17, 2012 | Supplement 11Manufacturing | Approved | None posted |
| Aug 23, 2004 | Supplement 2Labeling | Approved | None posted |
| Apr 25, 2000 | Original application | Approved |
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
