Nephrolithiasis

• FDA approval · 2024-05-30
  FDA Approved: POTASSIUM CITRATE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Potassium Citrate from Rising Pharma Holdings, Inc., under ANDA077440.

• FDA approval · 2023-04-10
  FDA Approved: POTASSIUM CITRATE EXTENDED RELEASE — Supplemental Application (Strides Pharma Inc.)

  FDA approved the supplemental application for Potassium Citrate Extended Release from Strides Pharma Inc., introducing an extended-release f…

• FDA approval · 2022-03-31
  FDA Approved: POTASSIUM CITRATE — Supplemental Application (Camber Pharmaceuticals, Inc)

  The FDA approved a supplemental application for Potassium citrate submitted by Camber Pharmaceuticals, Inc.

• FDA approval · 2021-12-10
  FDA Approved: POTASSIUM CITRATE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Potassium Citrate from Upsher-Smith Laboratories, updating labeling and/or indications.

• 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…

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• FDA approval · 2021-02-05
  FDA Approved: POTASSIUM CITRATE — Original Application (Camber Pharmaceuticals, Inc)

  FDA approves Camber Pharmaceuticals' original application for Potassium Citrate (generic). It is used to prevent kidney stones by alkalinizi…

• FDA approval · 2020-01-14
  FDA Approved: POTASSIUM CITRATE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' potassium citrate Original Application, a generic formulation for preventing nephrolithiasis (kidney stone…

• FDA approval · 2018-03-05
  FDA Approved: POTASSIUM CITRATE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic potassium citrate product by Actavis Pharma via original ANDA for the prevention of kidney stones related to hypocitr…

• FDA approval · 2017-09-11
  FDA Approved: POTASSIUM CITRATE EXTENDED RELEASE — Original Application (Strides Pharma Inc.)

  FDA approved the original application for Potassium Citrate Extended Release (generic) by Strides Pharma Inc., enabling a generic version of…

• FDA approval · 2015-01-26
  FDA Approved: LITHOSTAT — Supplemental Application (Mission Pharmacal Company)

  FDA approves a supplemental application for Lithostat (acetohydroxamic acid) submitted by Mission Pharmacal Company.

• FDA approval · 2014-08-06
  FDA Approved: POTASSIUM CITRATE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a generic potassium citrate product from Zydus Pharmaceuticals (USA) Inc. under an Original Application (ANDA203546) for the pr…

• FDA approval · 2014-07-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved the original application for Hydrochlorothiazide (ScieGen Pharmaceuticals, Inc.), a generic diuretic. It is indicated for hyper…

• FDA approval · 2006-06-08
  FDA Approved: POTASSIUM CITRATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original ANDA for Potassium citrate, authorizing a generic version of the drug.