Neurogenic Bladder

• FDA approval · 2020-10-27
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (Advagen Pharma Limited)

  FDA approved the generic oxybutynin chloride tablet from Advagen Pharma Limited under an Original Application.

• FDA approval · 2017-10-24
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin) filed by Allergan, Inc. This decision updates the product labeling.

• FDA approval · 2014-07-18
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin) from Allergan, Inc.

• FDA approval · 2013-08-30
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for oxybutynin chloride submitted by Chartwell RX, LLC.

• FDA approval · 2010-03-09
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for oxybutynin chloride from Teva Pharmaceuticals USA, updating the product labeling.

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• FDA approval · 2009-01-06
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' supplemental application for oxybutynin chloride. This action confirms approval of changes to the ge…

• FDA approval · 2007-02-01
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for oxybutynin chloride (Strides Pharma Science Limited) under ANDA075079. This action authorizes th…