Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 204010, held by Amneal Pharms. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 204010 (Oxybutynin Chloride), held by Amneal Pharms, was first approved by FDA on Nov 23, 2015, 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 |
|---|---|---|---|
| Nov 23, 2015 | 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 15Labeling · Standard review | Approved | None posted |
| Mar 13, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 19, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 23, 2015 | 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
