Treats clinically important hypotension occurring in the setting of anesthesia. NDA 208943, held by Ph Health. Ephedrine Sulfate.
As of Nov 13, 2026, NDA 208943 (Corphedra), held by Ph Health, was first approved by FDA on Jan 27, 2017, with 0 approved supplements and 0 published complete response letters.
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Corphedra50MG/ML (50MG/ML) · solution;intravenous | Ephedrine 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
