Treats acute cyanide poisoning. NDA 203923, held by Hope Pharms. Sodium Thiosulfate.
As of Nov 15, 2026, NDA 203923 (Sodium Thiosulfate), held by Hope Pharms, was first approved by FDA on Feb 14, 2012, with 3 approved supplements and 0 published complete response letters.
Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 2012 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Thiosulfate12.5GM/50ML (250MG/ML) · solution;intravenous | Sodium Thiosulfate | RxReference drug |
| May 7, 2026 | Supplement 5Manufacturing | Approved | None posted |
| Jun 19, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Oct 19, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Feb 14, 2012 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
