Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 206121, held by Unique. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 206121 (Oxybutynin Chloride), held by Unique, was first approved by FDA on May 27, 2016, with 4 approved supplements and 0 published complete response letters.
Oxybutynin chloride extended-release tablets are 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 |
|---|---|---|---|
| May 27, 2016 | 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 |
| May 24, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 28, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 27, 2016 | 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
