Nephrotic Syndrome

• FDA approval · 2018-07-18
  FDA Approved: SPIRONOLACTONE — Original Application (Zydus Lifesciences Limited)

  FDA approved the Original Application (ANDA) for spironolactone from Zydus Lifesciences Limited, marking a generic version of the diuretic.

• FDA approval · 2018-05-08
  FDA Approved: ETHACRYNIC ACID — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original generic application for Ethacrynic acid from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-04-30
  FDA Approved: BUMETANIDE — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved Bumetanide as a generic via Original Application (ANDA 202900), confirming bioequivalence to the reference product. It is indic…

• FDA approval · 2018-01-23
  FDA Approved: BUMETANIDE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Bumetanide under an Original Application for Upsher-Smith Laboratories, establishing a generic version of the loop diuretic.

• FDA approval · 2017-07-14
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc. The notice confirms regulatory approval o…

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• FDA approval · 2016-10-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide submitted by Marlex Pharmaceuticals, Inc.

• FDA approval · 2016-09-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

  FDA approves Hospira, Inc.'s supplemental application for furosemide, initiating a supplemental approval for the drug. The action updates th…

• FDA approval · 2016-09-19
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-09-19
  FDA Approved: SPIRONOLACTONE — Original Application (Accord Healthcare, Inc.)

  FDA approves Accord Healthcare, Inc.'s original application for spironolactone (generic), authorizing its use as a potassium-sparing diureti…

• FDA approval · 2016-07-20
  FDA Approved: FUROSEMIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for furosemide, authorizing a generic version of this diuretic.

• FDA approval · 2016-06-30
  FDA Approved: ETHACRYNIC ACID — Original Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved Edenbridge Pharmaceuticals' original application for Ethacrynic acid, a loop diuretic used to treat edema associated with h…

• FDA approval · 2016-03-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-03-04
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.

• FDA approval · 2015-09-28
  FDA Approved: BUMEX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Bumex (bumetanide) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2015-08-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC.

• FDA approval · 2015-07-29
  FDA Approved: ETHACRYNATE SODIUM — Original Application (Par Health USA, LLC)

  FDA approved Ethacrynate Sodium as an original ANDA for Par Health USA, LLC.

• FDA approval · 2015-06-05
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide from Marlex Pharmaceuticals, Inc., updating the product label.

• FDA approval · 2015-04-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…

• FDA approval · 2014-10-22
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for a generic spironolactone and hydrochlorothiazide combination product from Prasco Laboratories.

• FDA approval · 2014-10-20
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for bumetanide from Sandoz Inc.

• FDA approval · 2014-08-26
  FDA Approved: FUROSEMIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved Heritage Pharmaceuticals' generic furosemide (ANDA 203428) for edema-related indications and hypertension, enabling a generic v…

• FDA approval · 2014-04-23
  FDA Approved: SPIRONOLACTONE — Original Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved the original ANDA for spironolactone, authorizing a generic version manufactured by Jubilant Cadista Pharmaceuticals Inc.

• FDA approval · 2014-03-06
  FDA Approved: SPIRONOLACTONE — Original Application (NorthStar Rx LLC)

  The FDA approved NorthStar Rx LLC's Original Application for spironolactone (generic spironolactone).

• FDA approval · 2014-01-27
  FDA Approved: FUROSEMIDE — Original Application (Civica, Inc.)

  FDA approves Civica, Inc.’s original application for furosemide (generic diuretic).

• FDA approval · 2013-06-12
  FDA Approved: ALDACTONE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Aldactone (spironolactone) from Pfizer. The approval updates the drug’s labeling.