Overactive Bladder

• FDA approval · 2023-05-24
  FDA Approved: OXYBUTYNIN CHLORIDE EXTENDED RELEASE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for oxybutynin chloride extended-release by Rising Pharma Holdings, Inc., confirming the product and…

• FDA approval · 2023-02-27
  FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for fesoterodine fumarate by Zydus Pharmaceuticals USA Inc., granting approval for a generic fes…

• FDA approval · 2023-02-27
  FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fesoterodine fumarate from Aurobindo Pharma Limited, a generic treatment for overactive bladder.

• FDA approval · 2023-02-02
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for oxybutynin chloride from Accord Healthcare, Inc.

• FDA approval · 2023-02-02
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for oxybutynin chloride by Amneal Pharmaceuticals, updating the approved product under an abbreviate…

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• FDA approval · 2023-01-27
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Advagen Pharma Limited)

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

• FDA approval · 2023-01-04
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approval of Amneal's fesoterodine fumarate original application, a generic oral medication for overactive bladder.

• FDA approval · 2023-01-04
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals Inc.'s original application for fesoterodine fumarate, a generic treatment for overactive bladder.

• FDA approval · 2022-12-27
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for solifenacin succinate (generic) by Aurobindo Pharma Limited as a treatment option for overactive b…

• FDA approval · 2022-10-07
  FDA Approved: TROSPIUM CHLORIDE — Supplemental Application (Granules Pharmaceuticals Inc.)

  The FDA approved a supplemental application for trospium chloride from Granules Pharmaceuticals Inc. under ANDA213185. This confirms approva…

• FDA approval · 2022-09-29
  FDA Approved: MIRABEGRON — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original generic application for mirabegron, enabling Zydus Pharmaceuticals (USA) Inc. to market the generic form of mirabe…

• FDA approval · 2022-09-28
  FDA Approved: MIRABEGRON — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin's MIRABEGRON for the treatment of overactive bladder.

• FDA approval · 2022-08-25
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application for Oxybutynin Chloride submitted by Ajanta Pharma USA Inc.

• FDA approval · 2022-06-15
  FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' generic solifenacin succinate under an original ANDA submission, marking the approval of a generic vers…

• FDA approval · 2022-02-18
  FDA Approved: DARIFENACIN — Supplemental Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s supplemental application for darifenacin hydrobromide (DARIFENACIN). This action expands regulatory cleara…

• FDA approval · 2022-02-16
  FDA Approved: TROSPIUM CHLORIDE — Original Application (Zameer Pharmaceuticals LLC)

  FDA approved an original application for trospium chloride (generic) from Zameer Pharmaceuticals LLC, granting market authorization. It is i…

• FDA approval · 2022-01-26
  FDA Approved: SOLIFENACIN SUCCINATE — Supplemental Application (Novadoz Pharmaceuticals LLC)

  The FDA approved a supplemental application for solifenacin succinate from Novadoz Pharmaceuticals LLC, authorizing changes to the product l…

• FDA approval · 2021-12-03
  FDA Approved: SOLIFENACIN SUCCINATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Solifenacin succinate from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2021-10-18
  FDA Approved: OXYBUTYNIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA has approved a supplemental application for Oxybutynin from Zydus Pharmaceuticals USA Inc., indicating an updated approval for the p…

• FDA approval · 2021-09-15
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for oxybutynin chloride from Strides Pharma Science Limited. Oxybutynin chloride is used to treat ov…

• FDA approval · 2021-08-02
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' Tolterodine tartrate as an original generic application.

• FDA approval · 2021-06-17
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for TOVIAZ (fesoterodine fumarate) submitted by Pfizer to update its labeling.

• FDA approval · 2021-04-30
  FDA Approved: TROSPIUM CHLORIDE — Original Application (Slate Run Pharmaceuticals, LLC)

  The FDA approved Slate Run Pharmaceuticals' original application for trospium chloride, a generic version of the medication indicated for ov…

• FDA approval · 2021-03-25
  FDA Approved: MYRBETRIQ — Original Application (Astellas Pharma US, Inc.)

  FDA approves MYRBETRIQ (mirabegron) from Astellas Pharma US as the original NDA approval for overactive bladder.

• FDA approval · 2021-03-25
  FDA Approved: SOLIFENACIN SUCCINATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for solifenacin succinate from Ascend Laboratories, LLC. This action completes an approval proce…