Relieves symptoms of bladder instability associated with voiding. ANDA 209025, held by Rising. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 209025 (Oxybutynin Chloride), held by Rising, was first approved by FDA on Dec 21, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oxybutynin Chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2017 | Original application | Approved | None posted |
| Oxybutynin Chloride5MG · tablet;oral | Oxybutynin Chloride | Rx |
| Oxybutynin Chloride2.5MG · tablet;oral | Oxybutynin Chloride | Rx |
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
