NDA 22025, held by Clinigen. Dexrazoxane Hydrochloride.
As of Nov 15, 2026, NDA 22025 (Totect), held by Clinigen, was first approved by FDA on Sep 6, 2007, with 10 approved supplements and 0 published complete response letters.
| Nov 2, 2020 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Sep 6, 2007 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TotectEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dexrazoxane Hydrochloride | DiscontinuedReference drug |
| Apr 29, 2022 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 2, 2020 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Nov 16, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Feb 8, 2018 | Supplement 16Labeling · Standard review | Approved | |
| Jun 19, 2017 | Supplement 15Manufacturing | Approved | |
| Apr 26, 2013 | Supplement 13Labeling · Standard review | Approved | |
| Feb 12, 2013 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Mar 7, 2011 | Supplement 11Labeling | Approved | |
| Sep 16, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Feb 11, 2009 | Supplement 1Labeling · Standard review | Approved | |
| Sep 6, 2007 | Original applicationNew formulation or manufacturer · 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
