NDA 200179, held by Bayer Hlthcare. Vardenafil Hydrochloride.
As of Nov 14, 2026, NDA 200179 (Staxyn), held by Bayer Hlthcare, was first approved by FDA on Jun 17, 2010, with 6 approved supplements and 0 published complete response letters.
| Aug 2, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 2, 2013 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 17, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Staxyn10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Vardenafil Hydrochloride | DiscontinuedReference drug |
| Apr 24, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Aug 16, 2017 | Supplement 5Labeling · Standard review | Approved | |
| Aug 2, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 16, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Apr 29, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Aug 2, 2013 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 17, 2010 | 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
