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Aczone Approval History

  • FDA approved: Yes (First approved July 7th, 2005)
  • Brand name: Aczone
  • Generic name: dapsone
  • Company: Atrix Laboratories, Inc. and Fujisawa Healthcare, Inc.
  • Treatment for: Acne

Aczone (dapsone) is a sulfone in an aqueous gel base for topical dermatologic use. Aczone is indicated for the topical treatment of acne vulgaris.

FDA Approval History for Aczone

DateArticle
May 29, 2007QLT USA, Inc. files Aczone labeling supplement for removal of blood screening requirement
Sep  1, 2004Atrix and Fujisawa Submit New Drug Application for Acne Product

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