Overactive Bladder

• FDA approval · 2015-07-10
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for OXYTROL (oxybutynin). The approval updates the product labeling under NDA 021351.

• FDA approval · 2015-02-23
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's original application for Tolterodine Tartrate, a generic treatment for overactive bladder.

• FDA approval · 2015-02-09
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYRBETRIQ (mirabegron) from Astellas Pharma US, Inc.

• FDA approval · 2014-08-13
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for TOVIAZ (fesoterodine fumarate) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-07-28
  FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for tolterodine tartrate from Mylan Pharmaceuticals, marking an approved change related to its label…

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• 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 · 2014-05-16
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan, Inc.'s supplemental application for OXYTROL (oxybutynin). This action updates the product's labeling and/or indic…

• FDA approval · 2014-05-15
  FDA Approved: OXYTROL FOR WOMEN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL FOR WOMEN (oxybutynin) submitted by Allergan, Inc. This action updates the product's lab…

• FDA approval · 2014-03-13
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYRBETRIQ (mirabegron) filed by Astellas Pharma US, Inc., indicating an approved modification to…

• FDA approval · 2013-10-09
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) from Astellas Pharma US, Inc. The approval updates the drug's l…

• 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 · 2013-08-29
  FDA Approved: TROSPIUM CHLORIDE — Supplemental Application (Padagis US LLC)

  The FDA approved Padagis US LLC's supplemental application for trospium chloride, a generic drug used to treat overactive bladder.

• FDA approval · 2013-08-20
  FDA Approved: OXYTROL FOR WOMEN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL FOR WOMEN (oxybutynin) from Allergan, Inc., updating labeling related to the product.

• FDA approval · 2013-08-16
  FDA Approved: OXYTROL FOR WOMEN — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Oxytrol for Women (oxybutynin), a transdermal patch for overactive bladder in adult women.

• FDA approval · 2013-07-31
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

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

• FDA approval · 2013-07-31
  FDA Approved: TROSPIUM CHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves a supplemental application for trospium chloride (Glenmark Pharmaceuticals Inc., USA).

• FDA approval · 2013-07-19
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYRBETRIQ (mirabegron) submitted by Astellas Pharma US, Inc.

• FDA approval · 2013-07-03
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for OXYTROL (oxybutynin), updating the labeling for the product.

• FDA approval · 2013-05-29
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin), the transdermal patch from Allergan, Inc., signifying approval of updated …

• FDA approval · 2013-05-24
  FDA Approved: TROSPIUM CHLORIDE ER — Original Application (Padagis US LLC)

  FDA approved Padagis US LLC's original application for trospium chloride extended-release (trospium chloride ER), a generic version of the o…

• FDA approval · 2013-03-15
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

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

• FDA approval · 2013-03-04
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approves a supplemental application for MYRBETRIQ (mirabegron) by Astellas Pharma US, expanding the drug's label.

• FDA approval · 2013-01-25
  FDA Approved: OXYTROL FOR WOMEN — Original Application (Allergan, Inc.)

  The FDA approved OXYTROL FOR WOMEN (oxybutynin) under Allergan's original application. It is indicated for urinary symptoms associated with …

• FDA approval · 2013-01-23
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for TOVIAZ (fesoterodine fumarate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2012-11-30
  FDA Approved: TROSPIUM CHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for trospium chloride submitted by Glenmark Pharmaceuticals Inc., USA.