Treats known or suspected cyanide poisoning. NDA 22041, held by Btg Intl. Hydroxocobalamin.
As of Nov 14, 2026, NDA 22041 (Cyanokit), held by Btg Intl, was first approved by FDA on Dec 15, 2006, with 11 approved supplements and 0 published complete response letters.
CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2006 | Original applicationNew dosage form · Priority review | Approved |
| Cyanokit5GM/VIAL (5GM/KIT) · injectable;injection | Hydroxocobalamin | RxReference drug |
| Cyanokit2.5GM/VIAL (5GM/KIT) · injectable;injection | Hydroxocobalamin | Discontinued |
| Dec 31, 2018 | Supplement 19Labeling · Standard review | Approved | |
| Dec 31, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Feb 4, 2016 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Feb 4, 2016 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jul 3, 2014 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2013 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Apr 8, 2011 | Supplement 8Labeling · Priority review | Approved | |
| Apr 8, 2011 | Supplement 9Labeling · Standard review | Approved | |
| Oct 13, 2010 | Supplement 4Labeling · Standard review | Approved | |
| Feb 19, 2010 | Supplement 7Labeling | Approved | |
| Jun 4, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Dec 15, 2006 | Original applicationNew dosage form · Priority 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
