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Gelnique Approval History

  • FDA approved: Yes (First approved January 27th, 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

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