Renal Disease

• FDA approval · 2026-01-08
  FDA Approved: FUROSEMIDE — Original Application (Micro Labs Limited)

  FDA approved the original application for furosemide from Micro Labs Limited.

• FDA approval · 2025-07-17
  FDA Approved: FUROSEMIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's original ANDA for furosemide, a generic loop diuretic. The approval covers the generic product for i…

• FDA approval · 2025-06-13
  FDA Approved: BUMETANIDE — Supplemental Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for bumetanide from Qilu Pharmaceutical Co., Ltd., authorizing the generic product's approval.

• FDA approval · 2024-12-27
  FDA Approved: BUMETANIDE — Original Application (Advagen Pharma Limited)

  FDA approved Advagen Pharma Limited's original ANDA for bumetanide, a loop diuretic used to treat edema associated with congestive heart fai…

• FDA approval · 2024-12-13
  FDA Approved: FUROSEMIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original application for furosemide, enabling a generic version of the loop diuretic to be marketed.

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• FDA approval · 2024-09-19
  FDA Approved: BUMETANIDE — Original Application (Qilu Pharmaceutical Co., Ltd.)

  FDA approved bumetanide (Original Application) by Qilu Pharmaceutical as a generic diuretic for edema associated with congestive heart failu…

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

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

• FDA approval · 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 · 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…

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

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

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

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

• FDA approval · 2012-03-27
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2011-09-22
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA issued a supplemental approval for Torsemide from Rising Pharma Holdings, approving a generic torsemide product.

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for furosemide from Ipca Laboratories Limited under an ANDA, signaling approval of changes to the ge…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide filed by Hikma Pharmaceuticals USA Inc., updating the approved generic product un…

• FDA approval · 2010-09-28
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for torsemide submitted by Chartwell RX, LLC under ANDA 076894. The action approves changes to t…

• FDA approval · 2009-05-04
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2008-10-22
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

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

• FDA approval · 2008-04-30
  FDA Approved: BUMETANIDE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s original application for bumetanide, authorizing a generic version of the diuretic bumetanide.