Liver Cirrhosis

• 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 · 2022-04-12
  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 · 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 · 2020-12-02
  FDA Approved: METOLAZONE — Original Application (Alembic Pharmaceuticals Limited)

  Alembic Pharmaceuticals Limited's original application for metolazone received FDA approval, enabling the generic version to be marketed in …

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• 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 · 2020-02-19
  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 · 2019-08-06
  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 · 2019-07-12
  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 · 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 · 2018-04-30
  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 · 2017-10-18
  FDA Approved: BUMETANIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original application for bumetanide, granting approval of a generic bumetanide product.

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

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

• FDA approval · 2013-12-04
  FDA Approved: KIT FOR THE PREPARTION OF TECHNETIUM TC99M SULFUR COLLOID — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for a kit used to prepare Technetium-99m sulfur colloid for nuclear medicine imaging.

• 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.

• FDA approval · 2013-01-07
  FDA Approved: TORSEMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' torsemide supplemental application (ANDA 079234), resulting in an approved updated torsemide product un…

• FDA approval · 2012-11-30
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for furosemide from Ipca Laboratories Limited, indicating approval of their generic furosemide p…

• FDA approval · 2012-05-11
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., authorizing a generic version of the diuretic. Thi…

• FDA approval · 2011-11-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide submitted by Exelan Pharmaceuticals Inc.