Relieves symptoms of bladder instability associated with voiding. ANDA 211682, held by Heritage Pharma Avet. Oxybutynin Chloride.
As of Nov 15, 2026, ANDA 211682 (Oxybutynin Chloride), held by Heritage Pharma Avet, was first approved by FDA on May 10, 2019, with 1 approved supplement 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 |
|---|---|---|---|
| May 10, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxybutynin Chloride5MG · tablet;oral | Oxybutynin Chloride | Rx |
| May 10, 2019 | Original application | Approved | None posted |
| May 10, 2019 | Supplement 1 | 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
