Relieves symptoms of bladder instability associated with voiding. ANDA 74625, held by Aiping Pharm Inc. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 74625 (Oxybutynin Chloride), held by Aiping Pharm Inc, was first approved by FDA on Jul 31, 1996, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Jul 31, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG · tablet;oral | Oxybutynin Chloride | Rx |
| Jul 31, 2013 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 26, 2012 | Supplement 21Labeling | Approved | None posted |
| Apr 26, 2012 | Supplement 22Labeling | Approved | None posted |
| Mar 3, 2010 | Supplement 17Labeling | Approved | None posted |
| Jan 6, 2009 | Supplement 14Labeling | Approved | None posted |
| Dec 17, 2006 | Supplement 10Labeling | Approved | None posted |
| Jan 8, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Oct 30, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Sep 3, 1996 | Supplement 1Labeling | Approved | None posted |
| Jul 31, 1996 | 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
