Controls seizures in preeclampsia and eclampsia, respectively. ANDA 216597, held by Amneal. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 216597 (Magnesium Sulfate In Plastic Container), held by Amneal, was first approved by FDA on Feb 15, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Feb 15, 2023 | 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 |
| Jul 12, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 15, 2023 | Original application | Approved | None posted |
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
