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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

DateArticle
Jan 28, 2009Approval Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
May 28, 2008Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing byFDA for the Treatment of Overactive Bladder

Further information

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