Overactive Bladder

• FDA approval · 2010-04-07
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Chartwell RX, LLC)

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

• FDA approval · 2010-04-02
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Toviaz (fesoterodine fumarate) filed by Pfizer Laboratories Div Pfizer Inc, related to its l…

• 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.

• FDA approval · 2010-03-09
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for oxybutynin chloride from Strides Pharma Science Limited.

• FDA approval · 2010-03-03
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for oxybutynin chloride from Upsher-Smith Laboratories, LLC.

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• FDA approval · 2010-01-05
  FDA Approved: DETROL LA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Detrol LA (tolterodine tartrate) filed by Viatris Specialty LLC.

• FDA approval · 2009-04-08
  FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for tolterodine tartrate filed by Mylan Pharmaceuticals Inc. under NDA 020771.

• FDA approval · 2009-02-04
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for oxybutynin chloride, enabling a generic option for treating overactive bladder…

• 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 · 2009-01-06
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved the supplemental application for oxybutynin chloride submitted by Strides Pharma Science Limited. The approval covers changes a…

• FDA approval · 2008-10-31
  FDA Approved: TOVIAZ — Original Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved Toviaz (fesoterodine fumarate) from Pfizer as an oral treatment for adults with overactive bladder to relieve symptoms such…

• FDA approval · 2008-10-29
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) submitted by Astellas Pharma US, Inc.

• FDA approval · 2008-09-11
  FDA Approved: DETROL LA — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DETROL LA (tolterodine tartrate) from Viatris Specialty LLC.

• FDA approval · 2008-09-11
  FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for tolterodine tartrate filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2008-02-19
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for oxybutynin chloride by Teva Pharmaceuticals USA, resulting in changes to the existing approved p…

• FDA approval · 2008-02-08
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) from Astellas Pharma US, Inc., advancing a change to the produc…

• FDA approval · 2007-07-12
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Vesicare (solifenacin succinate) submitted by Astellas Pharma US, Inc., updating the drug's …

• FDA approval · 2007-04-24
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Vesicare (solifenacin succinate) from Astellas Pharma US, Inc. under NDA 021518.

• FDA approval · 2007-03-16
  FDA Approved: DETROL LA — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DETROL LA (tolterodine tartrate) from Viatris Specialty LLC.

• FDA approval · 2007-03-16
  FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for tolterodine tartrate submitted by Mylan Pharmaceuticals Inc., updating the product's labelin…

• 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…

• FDA approval · 2006-12-17
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for oxybutynin chloride from Upsher-Smith Laboratories, indicating an updated or expanded approval f…

• FDA approval · 2006-10-26
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

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

• FDA approval · 2006-07-05
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin) from Allergan, authorizing changes to the product via a supplemental submis…