Controls seizures in preeclampsia and eclampsia, respectively. ANDA 213917, held by Gland. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 213917 (Magnesium Sulfate In Plastic Container), held by Gland, was first approved by FDA on Jul 10, 2020, 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 preeclampsia 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 |
|---|---|---|---|
| Jul 10, 2020 | Original application | Approved | None posted |
| Magnesium Sulfate In Plastic Container2GM/50ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate In Plastic Container4GM/100ML (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
