Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. ANDA 211655, held by Ajanta Pharma Ltd. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 211655 (Oxybutynin Chloride), held by Ajanta Pharma Ltd, was first approved by FDA on Feb 28, 2019, with 2 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 is 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 28, 2019 | 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 |
| Aug 25, 2022 | Supplement 16Labeling · Standard review | Approved | None posted |
| Feb 28, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 28, 2019 | 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
