Hepatic Cirrhosis

• FDA approval · 2025-12-22
  FDA Approved: FUROSCIX — Supplemental Application (scPharmaceuticals Inc.)

  The FDA approved a supplemental application for FUROSCIX (furosemide injection 80 mg/10 mL) from scPharmaceuticals Inc.

• FDA approval · 2025-11-14
  FDA Approved: ALDACTONE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for Aldactone (spironolactone) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2025-10-07
  FDA Approved: LASIX ONYU — Original Application (SQ Innovation, Inc.)

  FDA approves LASIX ONYU for the same active ingredient furosemide under an Original Application by SQ Innovation, Inc. The product is now au…

• FDA approval · 2025-08-06
  FDA Approved: FUROSEMIDE — Supplemental Application (Meitheal Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic diuretic furosemide from Meitheal Pharmaceuticals Inc. under ANDA 212803.

• FDA approval · 2025-07-25
  FDA Approved: SPIRONOLACTONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic spironolactone under an original application (ANDA 217761).

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• FDA approval · 2024-11-06
  FDA Approved: METOLAZONE — Original Application (Micro Labs Limited)

  The FDA approved the generic METOLAZONE from Micro Labs Limited under an Original Application. This metolazone product is a thiazide-like di…

• FDA approval · 2024-09-17
  FDA Approved: BUMETANIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' bumetanide original application, granting a generic diuretic for edema associated with congestive he…

• 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 · 2023-04-20
  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 · 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 · 2022-08-31
  FDA Approved: FUROSEMIDE — Supplemental Application (Hospira, Inc.)

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

• 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 · 2021-08-20
  FDA Approved: METOLAZONE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's Original Application for METOLAZONE, granting approval of a generic diuretic.

• 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 · 2021-02-19
  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 · 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 · 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 · 2019-09-06
  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 · 2019-08-05
  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 · 2019-05-03
  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.