Heart Failure

• 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: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic Metoprolol Succinate product from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-05-05
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for metoprolol succinate from Zydus Pharmaceuticals (USA) Inc., approving its generic product under …

• 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 · 2023-04-14
  FDA Approved: KAPSPARGO — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for KAPSPARGO (metoprolol succinate) by Sun Pharmaceutical Industries.

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• FDA approval · 2023-04-04
  FDA Approved: ACETAZOLAMIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic acetazolamide product from Zydus Lifesciences Limited under an Original Application (ANDA211069).

• FDA approval · 2023-03-17
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for the Lisinopril and Hydrochlorothiazide combination from Lupin Pharmaceuticals, formalizing an ap…

• 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 · 2023-03-10
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for Toprol XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA approval · 2023-02-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for metoprolol succinate from Actavis Pharma, Inc., authorizing a generic extended-release metoprolo…

• 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 · 2023-01-27
  FDA Approved: CAPTOPRIL — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical’s Original Application for CAPTOPRIL (captopril), a generic ACE inhibitor. The approval supports indi…

• FDA approval · 2023-01-23
  FDA Approved: MILRINONE LACTATE — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)

  FDA approved the original application for milrinone lactate (generic) from Shandong New Time Pharmaceutical Co., Ltd. under ANDA216373. The …

• FDA approval · 2022-12-21
  FDA Approved: DOBUTAMINE — Original Application (Slate Run Pharmaceuticals)

  FDA approves Slate Run Pharmaceuticals' dobutamine—Original Application (ANDA 216131)—granting approval of a generic dobutamine product. Thi…

• FDA approval · 2022-12-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for the combination product spironolactone and hydrochlorothiazide, manufactured by Prasco Laborator…

• FDA approval · 2022-12-16
  FDA Approved: FUROSEMIDE — Original Application (Lifestar Pharma LLC)

  FDA approved Lifestar Pharma LLC's original application for furosemide, authorizing the generic version of the diuretic for its labeled indi…

• FDA approval · 2022-11-02
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc. This approval covers the changes reques…

• 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 · 2022-10-24
  FDA Approved: METOLAZONE — Original Application (Ingenus Pharmaceuticals LLC)

  FDA approves Metolazone via Original Application for a generic version by Ingenus Pharmaceuticals LLC. The approval supports its use for ede…

• FDA approval · 2022-10-17
  FDA Approved: FUROSEMIDE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings, Inc.'s original ANDA for furosemide, authorizing a generic version of this diuretic.

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

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

• FDA approval · 2022-08-26
  FDA Approved: CHLORTHALIDONE CHLORTHALIDONE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved an original application for a generic chlorthalidone by Alembic Pharmaceuticals Limited.

• FDA approval · 2022-08-17
  FDA Approved: VALSARTAN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  The FDA approved a supplemental application for valsartan from Jubilant Cadista Pharmaceuticals Inc. This approval indicates regulatory auth…

• FDA approval · 2022-08-16
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' supplemental application for metoprolol succinate ER tablets.

• 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…