Treats acute cyanide poisoning. NDA 203922, held by Hope Pharms. Sodium Nitrite.
As of Nov 13, 2026, NDA 203922 (Sodium Nitrite), held by Hope Pharms, was first approved by FDA on Feb 14, 2012, with 2 approved supplements and 0 published complete response letters.
Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate 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 potentially life-threatening risks associated with Sodium Nitrite 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 Nitrite300MG/10ML (30MG/ML) · solution;intravenous | Sodium Nitrite | RxReference drug |
| Jan 13, 2021 | Supplement 3Labeling · 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
