Overactive Bladder

• FDA approval · 2019-09-23
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for oxybutynin chloride from Accord Healthcare, indicating approval of changes to the product under …

• FDA approval · 2019-09-23
  FDA Approved: SOLIFENACIN SUCCINATE — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for solifenacin succinate submitted by Novadoz Pharmaceuticals LLC.

• FDA approval · 2019-09-09
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for oxybutynin chloride submitted by Chartwell RX, LLC. The approval confirms continuation of the ge…

• FDA approval · 2019-08-27
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves Unichem's original application for solifenacin succinate as a generic, enabling a generic version of the drug for overactive bl…

• FDA approval · 2019-08-19
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for oxybutynin chloride from Amneal Pharmaceuticals LLC.

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• FDA approval · 2019-08-19
  FDA Approved: OXYBUTYNIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for oxybutynin submitted by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2019-08-19
  FDA Approved: OXYBUTYNIN CHLORIDE EXTENDED RELEASE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for oxybutynin chloride extended-release filed by Rising Pharma Holdings, Inc. This approval mak…

• FDA approval · 2019-08-19
  FDA Approved: TOLTERODINE TARTRATE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' tolterodine tartrate as an original generic application, making tolterodine tartrate available as a generi…

• FDA approval · 2019-08-13
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Dr.Reddy's Laboratories Inc.,)

  The FDA approved fesoterodine fumarate from Dr. Reddy's Laboratories Inc. via an original ANDA for the treatment of overactive bladder sympt…

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Ascend Laboratories, LLC)

  FDA approves Ascend Laboratories' generic solifenacin succinate under an original application. It is approved for overactive bladder.

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' generic solifenacin succinate for overactive bladder via an original ANDA approval.

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's generic solifenacin succinate tablet under an original ANDA for the treatment of overactive bladder.

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approves the original application for solifenacin succinate (generic) for overactive bladder, supplied by ScieGen Pharmaceuticals, Inc.

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved a generic Solifenacin Succinate from Novadoz Pharmaceuticals LLC under an Original Application for the treatment of overactive …

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s solifenacin succinate as an Original Application (ANDA) for a generic version of the product. Solifena…

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s original ANDA for solifenacin succinate, a generic treatment for overactive bladder, providing a non-brand o…

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic version of solifenacin succinate for overactive bladder under ANDA 202551. Actavis Pharma, Inc. is the applicant.

• FDA approval · 2019-05-20
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Bostal LLC)

  The FDA approved the original application for Solifenacin succinate by Bostal LLC, making a generic version available. Solifenacin succinate…

• FDA approval · 2019-04-30
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Vesicare (solifenacin succinate) submitted by Astellas Pharma US, resulting in updated label…

• FDA approval · 2019-02-28
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s oxybutynin chloride as an original ANDA (ANDA211655), a generic product.

• FDA approval · 2018-09-06
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (TruPharma LLC)

  The FDA approved an Original Application for oxybutynin chloride from TruPharma LLC. This is a generic formulation for the treatment of over…

• FDA approval · 2018-07-13
  FDA Approved: DETROL LA — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2017-12-22
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (KVK-Tech, Inc.)

  FDA approved the original application for a generic oxybutynin chloride product from KVK-Tech, Inc. for the treatment of overactive bladder.

• FDA approval · 2017-12-21
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (RISING PHARMA HOLDINGS, INC.)

  The FDA approved oxybutynin chloride as a generic drug under an Original Abbreviated New Drug Application submitted by Rising Pharma Holding…

• FDA approval · 2017-12-12
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' tolterodine tartrate as an original application generic, for the treatment of overactive bladder wi…