Nephrotic Syndrome

• FDA approval · 2023-09-05
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.

• FDA approval · 2023-07-24
  FDA Approved: BUMETANIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original ANDA for bumetanide, a loop diuretic used to treat edema and related conditions.

• FDA approval · 2023-07-21
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for torsemide, granting approval of a generic torsemide product u…

• FDA approval · 2023-06-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for Spironolactone from Amneal Pharmaceuticals LLC.

• FDA approval · 2023-06-23
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for spironolactone by Oxford Pharmaceuticals, LLC. The approval allows continued marketing of the ge…

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• FDA approval · 2023-05-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's spironolactone and hydrochlorothiazide combination product. The submission …

• FDA approval · 2023-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2023-04-20
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide by Mylan Pharmaceuticals Inc., potentially updating label…

• FDA approval · 2023-02-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic Spironolactone and Hydrochlorothiazide from Mylan Pharmaceuticals Inc., a combinatio…

• FDA approval · 2022-12-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for the combination product spironolactone and hydrochlorothiazide, manufactured by Prasco Laborator…

• FDA approval · 2022-12-16
  FDA Approved: FUROSEMIDE — Original Application (Lifestar Pharma LLC)

  FDA approved Lifestar Pharma LLC's original application for furosemide, authorizing the generic version of the diuretic for its labeled indi…

• FDA approval · 2022-10-25
  FDA Approved: METOLAZONE — Original Application (Aarkish Pharmaceuticals NJ Inc.)

  FDA approved the original application for metolazone from Aarkish Pharmaceuticals NJ Inc., granting clearance to manufacture and market a ge…

• FDA approval · 2022-10-24
  FDA Approved: METOLAZONE — Original Application (Ingenus Pharmaceuticals LLC)

  FDA approves Metolazone via Original Application for a generic version by Ingenus Pharmaceuticals LLC. The approval supports its use for ede…

• FDA approval · 2022-10-17
  FDA Approved: FUROSEMIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original ANDA for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2022-08-31
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for furosemide from Hospira, Inc.

• FDA approval · 2022-08-04
  FDA Approved: BUMETANIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original ANDA for bumetanide (generic) by Novadoz Pharmaceuticals LLC for use in edema associated with congestive heart fai…

• FDA approval · 2022-07-06
  FDA Approved: TRIAMTERENE — Original Application (Biocon Pharma Inc.)

  The FDA approved Biocon Pharma Inc.'s original ANDA for Triamterene, granting generic approval to market Triamterene.

• FDA approval · 2022-05-26
  FDA Approved: BUMETANIDE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved Glenmark Pharmaceuticals USA's Original Application for bumetanide, authorizing the generic diuretic bumetanide for U.S. use.

• FDA approval · 2022-04-12
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA granted a supplemental approval for Furosemide by Phlow Corporation under the existing NDA; the snippet does not specify the exact natur…

• FDA approval · 2022-02-02
  FDA Approved: CYCLOSPORINE — Original Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan Pharmaceuticals' original application for cyclosporine, a generic immunosuppressant product. This makes a generic cyc…

• FDA approval · 2022-01-27
  FDA Approved: FUROSEMIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved an original generic application for furosemide from Meitheal Pharmaceuticals Inc.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves the original ANDA for Metolazone from Unichem Pharmaceuticals (USA), Inc., establishing its generic status.

• FDA approval · 2021-03-30
  FDA Approved: METOLAZONE — Original Application (Method Pharmaceuticals, LLC)

  FDA approved METOLAZONE under an original ANDA from Method Pharmaceuticals, LLC (generic approval).

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals, resulting in changes to the product labeling as p…

• FDA approval · 2021-02-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic spironolactone. This action confirms approval of modifications under…