Relieves symptoms of bladder instability associated with voiding. ANDA 208165, held by Strides Pharma. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 208165 (Oxybutynin Chloride), held by Strides Pharma, was first approved by FDA on Dec 17, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oxybutynin chloride tablets are 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 17, 2020 | 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
