Relieves symptoms of bladder instability associated with voiding. ANDA 209823, held by Novitium Pharma. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 209823 (Oxybutynin Chloride), held by Novitium Pharma, was first approved by FDA on Oct 23, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Oxybutynin chloride tablets, USP 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 |
|---|---|---|---|
| Oct 23, 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
