Hypertension

• FDA approval · 2024-01-08
  FDA Approved: ENALAPRIL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for enalapril maleate from Aurobindo Pharma Limited, a generic version of enalapril for cardiovascular…

• FDA approval · 2024-01-03
  FDA Approved: PRAZOSIN — Original Application (Lannett Company, Inc.)

  The FDA approved Lannett Company's original application for a generic prazosin product, a medication used to treat hypertension.

• FDA approval · 2023-12-27
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for metoprolol succinate (Toprol-XL) under an ANDA from Nivagen Pharmaceuticals.

• FDA approval · 2023-12-22
  FDA Approved: TENORETIC — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for Tenoretic, a fixed-dose combination of atenolol and chlorthalidone from Upsher-Smith Laborat…

• FDA approval · 2023-12-22
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for the bisoprolol fumarate and hydrochlorothiazide combination from Teva Pharmaceuticals USA, I…

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• FDA approval · 2023-12-22
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approves a supplemental application for Tenormin (atenolol) filed by Almatica Pharma LLC.

• FDA approval · 2023-12-21
  FDA Approved: TELMISARTAN — Supplemental Application (Modavar Pharmaceuticals LLC)

  The FDA approved a supplemental application for Telmisartan submitted by Modavar Pharmaceuticals LLC, resulting in an updated regulatory app…

• FDA approval · 2023-12-06
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental application for a generic Benazepril hydrochloride and hydrochlorothiazide combination ta…

• FDA approval · 2023-11-22
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited. The action confirms approval of changes to an…

• FDA approval · 2023-11-07
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc. The action confirms regulato…

• FDA approval · 2023-11-01
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for carvedilol, allowing continued marketing of the generic product.

• FDA approval · 2023-10-17
  FDA Approved: GUANFACINE — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's generic guanfacine as an approved product under ANDA 216762, confirming it as a generic version of guanfac…

• 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 · 2023-10-06
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydralazine Hydrochloride (generic) from Heritage Pharmaceuticals (d/b/a Avet Pharmaceutical…

• FDA approval · 2023-10-05
  FDA Approved: GUANFACINE — Original Application (A2A Integrated Pharmaceuticals)

  FDA approved the original application for guanfacine from A2A Integrated Pharmaceuticals, enabling generic guanfacine products to enter the …

• FDA approval · 2023-09-29
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic fixed-dose combination tablet containing amlodipine, valsartan, and hydrochlorothi…

• FDA approval · 2023-09-29
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals' generic fixed-dose combination tablet of losartan potassium and hydrochlorothiazide for the treatment…

• FDA approval · 2023-09-27
  FDA Approved: CLONIDINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for clonidine from Mylan Pharmaceuticals Inc., authorizing a generic clonidine product under an …

• FDA approval · 2023-09-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for metoprolol succinate from Nivagen Pharmaceuticals, Inc., authorizing changes to the product'…

• FDA approval · 2023-09-26
  FDA Approved: DOXAZOSIN — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for doxazosin from Accord Healthcare Inc., indicating an update to the approved generic product unde…

• FDA approval · 2023-09-20
  FDA Approved: NEBIVOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nebivolol from Aurobindo Pharma Limited. This action confirms the approval of an updated generic…

• FDA approval · 2023-09-20
  FDA Approved: NEBIVOLOL — Supplemental Application (AvKARE)

  FDA approved a supplemental application for Nebivolol hydrochloride (Nebivolol) manufactured by AvKARE.

• FDA approval · 2023-09-12
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Telmisartan and Hydrochlorothiazide from Alembic Pharmaceuticals Limited.

• FDA approval · 2023-09-12
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for metoprolol succinate from Mylan Pharmaceuticals Inc.

• FDA approval · 2023-09-11
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for the generic fixed-dose combination losartan potassium and hydrochlorothiazide from NorthStar Rx …