Gallstone Disease

• FDA approval · 2024-06-17
  FDA Approved: URSODIOL — Supplemental Application (KVK-Tech, Inc.)

  FDA approved a supplemental application for Ursodiol (ursodiol) filed by KVK-Tech, Inc. under ANDA210707. This action supports the continued…

• FDA approval · 2023-12-06
  FDA Approved: URSODIOL — Supplemental Application (Laurus Labs Limited)

  FDA approved Laurus Labs Limited's supplemental application for ursodiol (ursodeoxycholic acid) under an ANDA.

• FDA approval · 2023-11-28
  FDA Approved: URSODIOL — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for URSODIOL by Zydus Pharmaceuticals (USA) Inc.

• FDA approval · 2023-10-26
  FDA Approved: URSODIOL — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for ursodiol (ursodeoxycholic acid) from Lannett Company, Inc., adding changes to the existing appro…

• FDA approval · 2023-10-25
  FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Ursodiol from Strides Pharma Science Limited, expanding or updating its labeling/indications…

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• FDA approval · 2023-10-25
  FDA Approved: URSODIOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for URSODIOL from Aurobindo Pharma Limited, resulting in approval of the generic ursodiol product un…

• FDA approval · 2023-07-19
  FDA Approved: URSODIOL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for URSODIOL from Actavis Pharma, Inc.

• FDA approval · 2023-06-30
  FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)

  The FDA approved a supplemental application for Ursodiol (ursodiol) from Strides Pharma Science Limited.

• FDA approval · 2023-04-25
  FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for URSODIOL from BluePoint Laboratories.

• FDA approval · 2023-01-12
  FDA Approved: URSO 250 — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for URSO 250 (ursodiol) submitted by Allergan, Inc.

• FDA approval · 2021-11-29
  FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Ursodiol (URSODIOL) submitted by BluePoint Laboratories.

• FDA approval · 2020-08-17
  FDA Approved: URSODIOL — Original Application (Chartwell RX, LLC)

  FDA approved URSODIOL (ursodiol) from Chartwell RX, LLC under an Original Application (ANDA).

• FDA approval · 2020-02-12
  FDA Approved: URSODIOL — Original Application (Laurus Labs Limited)

  FDA approves Laurus Labs Limited's URSODIOL under an Original Application (ANDA) for a generic ursodiol product.

• FDA approval · 2018-10-16
  FDA Approved: URSODIOL — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's Ursodiol generic under an Original Application (ANDA 211301), enabling its marketing as a generic therapy.

• FDA approval · 2016-06-27
  FDA Approved: URSODIOL — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Ursodiol by Actavis Pharma, Inc., updating its labeling and indications. The action likely e…

• FDA approval · 2013-02-14
  FDA Approved: URSODIOL — Original Application (Endo USA, Inc.)

  The FDA approved Ursodiol (ursodeoxycholic acid) under an original ANDA submitted by Endo USA, Inc.

• FDA approval · 2011-07-12
  FDA Approved: URSODIOL — Original Application (BluePoint Laboratories)

  FDA approved the original (generic) application for URSODIOL from BluePoint Laboratories.

• FDA approval · 2009-11-25
  FDA Approved: URSO 250 — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for URSO 250 (ursodiol) from Allergan, Inc.

• FDA approval · 2009-10-22
  FDA Approved: CHENODAL — Original Application (Travere Therapeutics)

  The FDA approved CHENODAL (chenodiol) from Travere Therapeutics under an Original Application as a generic product. It is indicated for the …

• FDA approval · 2008-12-15
  FDA Approved: URSODIOL — Original Application (Lannett Company, Inc.)

  FDA approved URSODIOL as a new generic product from Lannett Company, Inc. via an Original Application (ANDA).