Heart Failure

• FDA approval · 2022-07-21
  FDA Approved: VALSARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for VALSARTAN from Amneal Pharmaceuticals LLC.

• 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 · 2022-06-30
  FDA Approved: RAMIPRIL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ramipril submitted by Zydus Lifesciences Limited under ANDA078832.

• FDA approval · 2022-06-29
  FDA Approved: ENALAPRIL MALEATE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves the original generic application for enalapril maleate (Enalapril) manufactured by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2022-06-01
  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. This action updates…

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• 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 · 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 · 2022-04-06
  FDA Approved: ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved Ingenus Pharmaceuticals' original application (ANDA 215586) for Isosorbide Dinitrate and Hydralazine Hydrochloride. The product…

• FDA approval · 2022-03-31
  FDA Approved: QUINAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a quinapril hydrochloride generic product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2022-03-30
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' enalapril maleate oral solution as an original generic application for enalapril; the drug is used to …

• FDA approval · 2022-03-11
  FDA Approved: DIGOXIN — Original Application (Amici Pharma, Inc)

  FDA approved the original ANDA for digoxin from Amici Pharma, authorizing a generic digoxin product.

• FDA approval · 2022-02-25
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories, enabling the marketing of t…

• FDA approval · 2022-02-24
  FDA Approved: JARDIANCE — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Jardiance (empagliflozin) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2022-02-24
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (NorthStar RxLLC)

  FDA approved NorthStar RxLLC's enalapril maleate oral solution as an original ANDA, enabling a generic version of enalapril maleate.

• FDA approval · 2022-02-24
  FDA Approved: CHLORTHALIDONE — Original Application (TAGI Pharma, Inc.)

  FDA approved the original generic application for chlorthalidone by TAGI Pharma, Inc., allowing market authorization for this thiazide-like …

• FDA approval · 2022-02-08
  FDA Approved: DIGOXIN — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic digoxin product, enabling marketing in the United States.

• FDA approval · 2022-01-27
  FDA Approved: FUROSEMIDE — Original Application (Meitheal Pharmaceuticals Inc.)

  FDA approved an original generic application for furosemide from Meitheal Pharmaceuticals Inc.

• FDA approval · 2021-12-23
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for lisinopril submitted by Camber Pharmaceuticals, Inc., approving changes to the lisinopril pr…

• FDA approval · 2021-12-06
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan submitted by Aurobindo Pharma Limited, updating the existing approval for this generic…

• FDA approval · 2021-12-06
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for VALSARTAN from Macleods Pharmaceuticals Limited. This approval supports continued distribution o…

• FDA approval · 2021-11-22
  FDA Approved: DIGOXIN — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' generic digoxin product (DIGOXIN) under an original ANDA. Digoxin is used to treat heart failure and certa…

• FDA approval · 2021-11-08
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for a generic metoprolol succinate product from Epic Pharma, LLC.

• FDA approval · 2021-11-02
  FDA Approved: VALSARTAN — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original ANDA for valsartan, enabling generic manufacture and marketing of valsartan for its approved …

• FDA approval · 2021-10-27
  FDA Approved: VALSARTAN — Original Application (ScieGen Pharmaceuticals, INC.)

  FDA approves the original application for VALSARTAN (Valsartan) from ScieGen Pharmaceuticals as a generic angiotensin II receptor blocker. I…

• FDA approval · 2021-10-25
  FDA Approved: EPLERENONE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approves Westminster Pharmaceuticals' original ANDA for EPLERENONE (generic eplerenone), providing a generic option for hypertension and…