Controls seizures in pre-eclampsia and eclampsia, respectively. ANDA 207967, held by B Braun Medical. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 207967 (Magnesium Sulfate), held by B Braun Medical, was first approved by FDA on Apr 26, 2021, 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 |
|---|---|---|---|
| Apr 26, 2021 | Original application | Approved | None posted |
| Magnesium Sulfate2GM/50ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate4GM/100ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Rx |
| Magnesium Sulfate4GM/50ML (80MG/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
