NDA 21518, held by Astellas. Solifenacin Succinate.
As of Nov 14, 2026, NDA 21518 (Vesicare), held by Astellas, was first approved by FDA on Nov 19, 2004, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2004 | Original applicationNew molecular entity · Standard review | Approved |
| Vesicare5MG · tablet;oral | Solifenacin Succinate | DiscontinuedReference drug |
| Vesicare10MG · tablet;oral | Solifenacin Succinate | DiscontinuedReference drug |
| May 26, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Apr 30, 2019 | Supplement 18Labeling · Standard review | Approved | |
| Oct 9, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Mar 29, 2013 | Supplement 15Labeling · Standard review | Approved | |
| Aug 3, 2012 | Supplement 14Labeling · Standard review | Approved | |
| Jul 13, 2012 | Supplement 13Labeling · Standard review | Approved | |
| Jun 7, 2012 | Supplement 11Labeling · Standard review | Approved | |
| Jan 17, 2012 | Supplement 12Labeling · Standard review | Approved | |
| Mar 10, 2011 | Supplement 10Labeling | Approved | |
| Jul 12, 2010 | Supplement 8Labeling · Standard review | Approved | |
| Nov 18, 2008 | Supplement 7Labeling · Standard review | Approved | |
| Oct 29, 2008 | Supplement 6Labeling · Standard review | Approved | |
| Feb 8, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Jul 12, 2007 | Supplement 3Labeling · Standard review | Approved | |
| Apr 24, 2007 | Supplement 2Manufacturing | Approved | None posted |
| Nov 19, 2004 | Original applicationNew molecular entity · 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
