Gelnique Approval History
FDA Approved: Yes (First approved January 27, 2009)
Brand name: Gelnique
Generic name: oxybutynin hydrochloride
Dosage form: Topical Gel
Previous Name: OTG
Company: Watson Pharmaceuticals, Inc.
Treatment for: Overactive Bladder
Gelnique (oxybutynin chloride) Gel is a transdermal antispasmodic which is applied to the skin once daily for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency.
Development History and FDA Approval Process for Gelnique
|Jan 28, 2009||Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder|
|May 28, 2008||Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing byFDA for the Treatment of Overactive Bladder|