Cystinuria

• FDA approval · 2025-08-29
  FDA Approved: TIOPRONIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application from Amneal Pharmaceuticals NY LLC for Tiopronin, enabling a generic Tiopronin product to be markete…

• FDA approval · 2024-07-26
  FDA Approved: VENXXIVA — Supplemental Application (Cycle Pharmaceuticals Ltd.)

  The FDA approved a supplemental application for VENXXIVA (tiopronin) submitted by Cycle Pharmaceuticals Ltd. under ANDA216990. The action au…

• FDA approval · 2024-07-22
  FDA Approved: TIOPRONIN — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva's original application for Tiopronin as a generic drug for the treatment of cystinuria to prevent kidney stone formation.

• FDA approval · 2024-01-30
  FDA Approved: VENXXIVA — Original Application (Cycle Pharmaceuticals Ltd.)

  FDA approved VENXXIVA (tiopronin) from Cycle Pharmaceuticals Ltd. under an Original Application (ANDA216990).

• FDA approval · 2023-08-15
  FDA Approved: TIOPRONIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA (216278) for Tiopronin from Amneal Pharmaceuticals NY LLC, providing a generic option for treating cystinuria…

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• FDA approval · 2023-02-24
  FDA Approved: TIOPRONIN — Original Application (Endo USA, Inc.)

  FDA approved an original generic application for Tiopronin, manufactured by Endo USA, Inc., for use in patients with cystinuria to prevent k…

• FDA approval · 2021-08-23
  FDA Approved: PENICILLAMINE — Original Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's penicillamine under its original application (ANDA 215409), enabling a generic version of pen…

• FDA approval · 2021-03-08
  FDA Approved: THIOLA EC — Supplemental Application (Mission Pharmacal Company)

  FDA approved a supplemental application for THIOLA EC (tiopronin) from Mission Pharmacal Company, adding the extended-release formulation to…

• FDA approval · 2020-08-04
  FDA Approved: PENICILLAMINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' original application for penicillamine, a chelating agent used to treat Wilson's disease and cystinur…

• FDA approval · 2019-12-23
  FDA Approved: PENICILLAMINE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original application for penicillamine as a generic drug product.

• FDA approval · 2019-06-28
  FDA Approved: THIOLA EC — Original Application (Mission Pharmacal Company)

  FDA approved THIOLA EC (tiopronin) as an enteric-coated formulation under Mission Pharmacal Company's original NDA for the prevention of rec…

• FDA approval · 2019-06-28
  FDA Approved: THIOLA — Supplemental Application (Mission Pharmacal Company)

  FDA approved a supplemental application for Thiola (tiopronin) from Mission Pharmacal Company, expanding its approved indication to prevent …