Nephrotic Syndrome

• FDA approval · 2021-02-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide by Prasco Laboratories, authorizing its marketing as …

• FDA approval · 2021-01-27
  FDA Approved: FUROSEMIDE — Original Application (Sagent Pharmaceuticals)

  FDA approved a new generic version of furosemide from Sagent Pharmaceuticals under an original application, enabling market entry as a loop …

• FDA approval · 2020-12-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for furosemide from Marlex Pharmaceuticals, Inc., indicating an additional/or updated approval f…

• FDA approval · 2020-07-01
  FDA Approved: FUROSEMIDE — Original Application (Gland Pharma Limited)

  FDA approves the original generic application for furosemide from Gland Pharma Limited.

• FDA approval · 2020-05-31
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approves a supplemental ANDA for furosemide from Solco Healthcare LLC.

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• FDA approval · 2020-05-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved Ipca Laboratories Limited's supplemental application for furosemide under an ANDA, updating the approved product.

• FDA approval · 2020-05-04
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Torsemide from Rising Pharma Holdings, Inc. under an ANDA (ANDA078249).

• FDA approval · 2020-05-04
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc., under the Torsemide product line.

• FDA approval · 2020-04-06
  FDA Approved: BUMETANIDE — Supplemental Application (NorthStar Rx, LLC)

  The FDA approved a supplemental application for bumetanide submitted by NorthStar Rx, LLC.

• FDA approval · 2020-04-06
  FDA Approved: BUMETANIDE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for bumetanide (generic) under an ANDA.

• FDA approval · 2020-02-19
  FDA Approved: ETHACRYNIC ACID — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith's original generic application for Ethacrynic acid, a loop diuretic.

• FDA approval · 2019-12-12
  FDA Approved: BUMETANIDE — Original Application (Rising Pharma Holdings, Inc)

  FDA approved an original ANDA for bumetanide from Rising Pharma Holdings, Inc, making the generic diuretic available.

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for spironolactone from Mylan Pharmaceuticals Inc., enabling continued marketing of the product and …

• FDA approval · 2019-11-14
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA has approved a supplemental application for spironolactone from Jubilant Cadista Pharmaceuticals Inc. under the ANDA framework.

• FDA approval · 2019-09-06
  FDA Approved: ETHACRYNIC ACID — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s Original Application for Ethacrynic acid, authorizing a generic version of the loop diuretic. Thi…

• FDA approval · 2019-08-27
  FDA Approved: ETHACRYNIC ACID — Original Application (ScieGen Pharmaceuticals Inc)

  FDA approved Ethacrynic acid from ScieGen Pharmaceuticals Inc under an Original Application (ANDA211232).

• FDA approval · 2019-08-06
  FDA Approved: CHLORTHALIDONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original application for chlorthalidone from Unichem Pharmaceuticals (USA), Inc., enabling a generic version of the diureti…

• FDA approval · 2019-08-05
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for spironolactone, enabling the marketing of a new generic product.

• FDA approval · 2019-07-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for spironolactone submitted by Sun Pharmaceutical Industries, Inc., indicating an update to the…

• FDA approval · 2019-07-12
  FDA Approved: ETHACRYNIC ACID — Original Application (TRUPHARMA LLC)

  FDA approves the original ANDA for Ethacrynic acid by Trupharma LLC, enabling its generic distribution as a loop diuretic. The approval cove…

• FDA approval · 2019-05-03
  FDA Approved: FUROSEMIDE — Original Application (Eugia US LLC)

  FDA approved an original ANDA for FUROSEMIDE by Eugia US LLC, confirming a generic version of the diuretic. This is a routine generic drug a…

• FDA approval · 2019-04-24
  FDA Approved: BUMETANIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Bumetanide from Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., confirming a new generic form of the drug.

• FDA approval · 2019-02-26
  FDA Approved: CHLORTHALIDONE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for chlorthalidone, a generic diuretic. This enables marketing of the generic chlo…

• FDA approval · 2018-08-08
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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