NDA 21673, held by Genzyme. Clofarabine.
As of Nov 14, 2026, NDA 21673 (Clolar), held by Genzyme, was first approved by FDA on Dec 28, 2004, with 9 approved supplements and 0 published complete response letters.
| Jul 18, 2022 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2008 | Supplement 5Efficacy (new indication or use) | Approved | |
| Dec 28, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clolar20MG/20ML (1MG/ML) · solution;intravenous | Clofarabine | DiscontinuedReference drug |
| Jul 18, 2022 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2019 | Supplement 26Labeling · Standard review | Approved | |
| Oct 27, 2016 | Supplement 25Labeling · Standard review | Approved | |
| Dec 16, 2015 | Supplement 24Labeling · Standard review | Approved | |
| Sep 15, 2014 | Supplement 23Labeling · Standard review | Approved | |
| Jan 10, 2013 | Supplement 22Labeling · Standard review | Approved | |
| Jun 10, 2011 | Supplement 10Labeling · Standard review | Approved | |
| Oct 17, 2008 | Supplement 5Efficacy (new indication or use) | Approved | |
| Oct 17, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Dec 28, 2004 | Original applicationNew molecular entity · 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
