Relieves symptoms of bladder instability associated with voiding. ANDA 210125, held by Tp Anda Holdings. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 210125 (Oxybutynin Chloride), held by Tp Anda Holdings, was first approved by FDA on Sep 6, 2018, 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 |
|---|---|---|---|
| Sep 6, 2018 | 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
