Relieves symptoms of bladder instability associated with voiding. ANDA 74520, held by Lannett Co Inc. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 74520 (Oxybutynin Chloride), held by Lannett Co Inc, was first approved by FDA on Mar 29, 1996, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oxybutynin Chloride Syrup 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 |
|---|---|---|---|
| Mar 29, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG/5ML · syrup;oral | Oxybutynin Chloride | Rx |
| Nov 2, 2011 | Supplement 5Labeling | Approved | None posted |
| Sep 20, 2010 | Supplement 4Labeling | Approved | None posted |
| Jul 11, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Mar 4, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Mar 4, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Mar 29, 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
