Controls seizures in pre-eclampsia and eclampsia, respectively. ANDA 217461, held by Adaptis. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 217461 (Magnesium Sulfate), held by Adaptis, was first approved by FDA on Jul 9, 2026, with 0 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2026 | Original application | Approved | None posted |
| Magnesium Sulfate1GM/2ML (500MG/ML) · solution;intramuscular, intravenous | Magnesium Sulfate | Rx |
| Magnesium Sulfate5GM/10ML (500MG/ML) · solution;intramuscular, intravenous | Magnesium Sulfate | Rx |
| Magnesium Sulfate10GM/20ML (500MG/ML) · solution;intramuscular, intravenous | Magnesium Sulfate | Rx |
| Magnesium Sulfate25GM/50ML (500MG/ML) · solution;intramuscular, intravenous | Magnesium Sulfate | Rx |
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
