Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 207138, held by Accord Hlthcare. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 207138 (Oxybutynin Chloride), held by Accord Hlthcare, was first approved by FDA on Feb 29, 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 |
|---|---|---|---|
| Feb 29, 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 |
| Feb 2, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 23, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 5, 2017 | Supplement 3Manufacturing | Approved | None posted |
| Jan 5, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 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
