Controls seizures in pre-eclampsia and eclampsia, respectively. ANDA 206486, held by Fresenius Kabi USA. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 206486 (Magnesium Sulfate In Dextrose 5% In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Mar 7, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Magnesium sulfate in 5% dextrose injection, USP 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Magnesium Sulfate In Dextrose 5% In Plastic Container1GM/100ML · injectable;injection | 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
