Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 202332, held by Zydus Pharms. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 202332 (Oxybutynin Chloride), held by Zydus Pharms, was first approved by FDA on Jun 26, 2017, with 3 approved supplements and 0 published complete response letters.
Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 2017 | Original application | Approved | None posted |
| Oxybutynin Chloride5MG · tablet, extended release;oral | Oxybutynin Chloride | Rx |
| Oxybutynin Chloride10MG · tablet, extended release;oral | Oxybutynin Chloride | Rx |
| Oxybutynin Chloride15MG · tablet, extended release;oral | Oxybutynin Chloride | Rx |
| Oct 18, 2021 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 28, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 26, 2017 | Original application | Approved | None posted |
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
