Relieves symptoms of bladder instability associated with voiding. ANDA 75079, held by Strides Pharma Intl. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 75079 (Oxybutynin Chloride), held by Strides Pharma Intl, was first approved by FDA on Oct 31, 1997, with 8 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 |
|---|---|---|---|
| Oct 31, 1997 | Original application | Approved | None posted |
| Oxybutynin Chloride5MG · tablet;oral | Oxybutynin Chloride | Rx |
| Oxybutynin Chloride2.5MG · tablet;oral | Oxybutynin Chloride | Rx |
| Sep 15, 2021 | Supplement 21Manufacturing | Approved | None posted |
| Jun 13, 2012 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 26, 2012 | Supplement 10Labeling | Approved | None posted |
| Nov 4, 2011 | Supplement 9Labeling | Approved | None posted |
| Mar 9, 2010 | Supplement 7Labeling | Approved | None posted |
| Jan 6, 2009 | Supplement 6Labeling | Approved | None posted |
| Feb 1, 2007 | Supplement 5Labeling | Approved | None posted |
| Feb 23, 2006 | Supplement 4Labeling | Approved | None posted |
| Oct 31, 1997 | 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
