NDA 22204, held by Abbvie. Oxybutynin Chloride.
As of Nov 13, 2026, NDA 22204 (Gelnique), held by Abbvie, was first approved by FDA on Jan 27, 2009, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gelnique10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · gel;transdermal | Oxybutynin Chloride | DiscontinuedReference drug |
| Oct 25, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Aug 4, 2015 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 10, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Aug 12, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 10, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Jan 31, 2011 | Supplement 4Labeling · Standard review | Approved | |
| Jan 27, 2009 | 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
