ANDA 209911, held by Pharmobedient. Magnesium Sulfate.
As of Nov 15, 2026, ANDA 209911 (Magnesium Sulfate In Plastic Container), held by Pharmobedient, was first approved by FDA on Sep 14, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2018 | Original application | Approved | None posted |
| Magnesium Sulfate In Plastic Container2GM/50ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Discontinued |
| Magnesium Sulfate In Plastic Container4GM/100ML (40MG/ML) · injectable;injection | Magnesium Sulfate | Discontinued |
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