Treats benign prostatic hyperplasia (BPH). NDA 21269, held by Viatris. Doxazosin Mesylate.
As of Nov 14, 2026, NDA 21269 (Cardura Xl), held by Viatris, was first approved by FDA on Feb 22, 2005, with 8 approved supplements and 0 published complete response letters.
CARDURA XL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CARDURA XL is not indicated for the treatment of hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 22, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Cardura XlEQ 4MG BASE · tablet, extended release;oral | Doxazosin Mesylate | RxReference drug |
| Cardura XlEQ 8MG BASE · tablet, extended release;oral | Doxazosin Mesylate | RxReference drug |
| Jun 22, 2021 | Supplement 21Labeling · Standard review | Approved | |
| Feb 27, 2017 | Supplement 18Labeling · Standard review | Approved | |
| Jun 8, 2015 | Supplement 17Labeling · Standard review | Approved | |
| Jul 28, 2014 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2012 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 8, 2011 | Supplement 12Labeling | Approved | |
| Mar 16, 2010 | Supplement 11Labeling · Standard review | Approved | |
| Mar 24, 2006 | Supplement 1Labeling · Standard review | Approved | |
| Feb 22, 2005 | Original applicationNew dosage form · 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
