Cholelithiasis

• FDA approval · 2025-11-21
  FDA Approved: URSODIOL — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for URSODIOL submitted by Strides Pharma Science Limited. This action updates the drug's approval st…

• FDA approval · 2022-11-28
  FDA Approved: URSODIOL — Original Application (Aurobindo Pharma Limited)

  FDA approved URSODIOL (ursodiol) as an Original Application for a generic formulation filed by Aurobindo Pharma Limited. The approval covers…

• FDA approval · 2021-01-22
  FDA Approved: URSODIOL — Original Application (Strides Pharma Science Limited)

  FDA approval of an original ANDA for Ursodiol (ursodeoxycholic acid) for Strides Pharma Science Limited, enabling its generic production. It…

• FDA approval · 2015-10-26
  FDA Approved: URSODIOL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for URSODIOL (ursodiol) from BluePoint Laboratories. This confirms regulatory clearance for the …

• FDA approval · 2013-08-21
  FDA Approved: URSO 250 — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for URSO 250 (ursodiol), adding a 250 mg strength to the product label.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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 …