NDA 202211, held by Abbvie. Oxybutynin.
As of Nov 14, 2026, NDA 202211 (Oxytrol For Women), held by Abbvie, was first approved by FDA on Jan 25, 2013, with 4 approved supplements and 0 published complete response letters.
Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 2013 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxytrol For Women3.9MG/24HR · film, extended release;transdermal | Oxybutynin | OTCReference drug |
| Mar 3, 2016 | Supplement 4Labeling · Standard review | Approved | |
| May 15, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Aug 20, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 16, 2013 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 25, 2013 | Original applicationTYPE 8 · 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
