Relieves symptoms of bladder instability associated with voiding. ANDA 75039, held by Chartwell Rx. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 75039 (Oxybutynin Chloride), held by Chartwell Rx, was first approved by FDA on Jan 29, 1999, with 2 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 |
|---|---|---|---|
| Jan 29, 1999 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG/5ML · syrup;oral | Oxybutynin Chloride | Rx |
| Oct 26, 2006 | Supplement 4Labeling | Approved | None posted |
| Aug 13, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Jan 29, 1999 | Original application | Approved | None posted |
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
