Edema

• FDA approval · 2024-05-15
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA has approved a supplemental application for acetazolamide submitted by Lifestar Pharma LLC.

• FDA approval · 2024-04-30
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Accord Healthcare Inc. under ANDA 202556. The document does not…

• FDA approval · 2024-04-30
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by ScieGen Pharmaceuticals Inc., endorsing changes to the prod…

• FDA approval · 2024-04-04
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Hydrochlorothiazide from Aurobindo Pharma Limited (generic).

• FDA approval · 2024-04-02
  FDA Approved: FUROSEMIDE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s original application for a generic furosemide product, enabling its marketing in the United States.

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• FDA approval · 2024-03-21
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for Hydrochlorothiazide from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-03-19
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from Zydus Lifesciences Limited to market the generic co…

• FDA approval · 2024-01-08
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approves a supplemental application for Triamterene and Hydrochlorothiazide submitted by Chartwell RX, LLC.

• FDA approval · 2023-10-23
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for hydrochlorothiazide from Oxford Pharmaceuticals, LLC. This action pertains to regulatory approva…

• FDA approval · 2023-10-10
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for spironolactone by Mylan Pharmaceuticals Inc., updating the approval for this generic diuretic. T…

• FDA approval · 2023-09-05
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for spironolactone from Amneal Pharmaceuticals NY LLC, enabling a generic version of the diuretic.

• FDA approval · 2023-08-25
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for acetazolamide sodium filed by Mylan Institutional LLC, approving the salt form of acetazolamide …

• FDA approval · 2023-08-24
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for spironolactone from Padagis US LLC, indicating an updated regulatory action on this product (sup…

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (TRUPHARMA, LLC)

  FDA approved a supplemental application for acetazolamide from TRUPHARMA, LLC under ANDA 211372. This action updates the approval status of …

• FDA approval · 2023-08-16
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Eywa Pharma Inc)

  The FDA approved Eywa Pharma Inc's supplemental application for acetazolamide, enabling continued marketing of a generic acetazolamide produ…

• FDA approval · 2023-08-09
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for acetazolamide, finalizing approval for changes to the approved generic produc…

• 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 · 2023-06-23
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for spironolactone by Oxford Pharmaceuticals, LLC. The approval allows continued marketing of the ge…

• FDA approval · 2023-05-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's spironolactone and hydrochlorothiazide combination product. The submission …

• FDA approval · 2023-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

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

• FDA approval · 2023-05-09
  FDA Approved: ACETAZOLAMIDE — Original Application (Marlex Pharmaceuticals, Inc.)

  FDA approved acetazolamide as an original ANDA from Marlex Pharmaceuticals, providing a generic version of the carbonic anhydrase inhibitor.…

• 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 · 2023-03-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydrochlorothiazide submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals In…

• FDA approval · 2023-02-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic Spironolactone and Hydrochlorothiazide from Mylan Pharmaceuticals Inc., a combinatio…

• FDA approval · 2023-01-23
  FDA Approved: ACETAZOLAMIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetazolamide (generic) submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals In…