Prevents eclampsia. ANDA 207966, held by B Braun Medical. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 207966 (Magnesium Sulfate In Dextrose 5% In Plastic Container), held by B Braun Medical, was first approved by FDA on Oct 27, 2020, with 0 approved supplements and 0 published complete response letters.
Magnesium Sulfate in 5% Dextrose Injection is indicated for: Prevention of eclampsia in patients with preeclampsia Treatment of seizures and prevention of recurrent seizures in patients with eclampsia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2020 | 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
