Relieves symptoms of bladder instability associated with voiding. ANDA 209335, held by Abhai LLC. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 209335 (Oxybutynin Chloride), held by Abhai LLC, was first approved by FDA on Dec 22, 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 22, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG · 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
