Controls seizures in pre-eclampsia and eclampsia, respectively. ANDA 206485, held by Fresenius Kabi USA. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 206485 (Magnesium Sulfate In Plastic Container), held by Fresenius Kabi USA, was first approved by FDA on Mar 15, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Magnesium sulfate in water for injection 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 15, 2016 | Original application | Approved | None posted |
| Magnesium Sulfate In Plastic Container4GM/100ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate In Plastic Container4GM/50ML (80MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate In Plastic Container2GM/50ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate In Plastic Container20GM/500ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate In Plastic Container40GM/1000ML (40MG/ML) · 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
