Hypertension

• 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: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for the generic fixed-dose combination IRBESARTAN AND HYDROCHLOROTHIAZIDE from Alembic Pharmaceutica…

• FDA approval · 2023-08-25
  FDA Approved: NEBIVOLOL — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves ANI Pharmaceuticals' supplemental application for Nebivolol, enabling a generic nebivolol product.

• FDA approval · 2023-08-25
  FDA Approved: NEBIVOLOL — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Nebivolol from Ascend Laboratories, LLC, indicating an updated regulatory approval for the drug.

• FDA approval · 2023-08-25
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's supplemental application for a generic telmisartan/hydrochlorothiazide combination tablet.

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• 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 · 2023-08-23
  FDA Approved: NEBIVOLOL — Supplemental Application (Lifestar Pharma LLC)

  The FDA approved a supplemental application for Nebivolol submitted by Lifestar Pharma LLC.

• FDA approval · 2023-08-23
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for losartan potassium from Micro Labs Limited under an ANDA, indicating an update to the drug's app…

• FDA approval · 2023-08-14
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original application for losartan potassium (a generic product) by Novadoz Pharmaceuticals LLC.

• FDA approval · 2023-08-11
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's generic valsartan/hydrochlorothiazide tablet for hypertension under an original application.

• FDA approval · 2023-08-10
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, a generic combination product for hypertension manu…

• FDA approval · 2023-08-10
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from Unichem Pharmaceuticals (USA), Inc., signali…

• FDA approval · 2023-08-07
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules India Ltd)

  FDA approved METOPROLOL SUCCINATE (extended-release) as an original generic application from Granules India Ltd, enabling its marketing for …

• FDA approval · 2023-07-31
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Losartan Potassium and Hydrochlorothiazide, a combination product. The appr…

• FDA approval · 2023-07-28
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for a generic losartan potassium and hydrochlorothiazide product from Macleods Pharmaceuticals Limit…

• FDA approval · 2023-07-26
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC.

• FDA approval · 2023-07-21
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for torsemide, granting approval of a generic torsemide product u…

• FDA approval · 2023-07-20
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for the generic combination medication losartan potassium and hydrochlorothiazide manufactured b…

• FDA approval · 2023-07-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Burel Pharmaceuticals, LLC)

  FDA approved the original application for NICARDIPINE HYDROCHLORIDE filed by Burel Pharmaceuticals, LLC, authorizing a generic version of ni…

• FDA approval · 2023-07-14
  FDA Approved: TELMISARTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's supplemental application for telmisartan (generic), enabling the generic telmisartan product to be marketed under the A…

• FDA approval · 2023-07-14
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Solco Healthcare US, LLC)

  FDA approved the generic bisoprolol fumarate tablet from Solco Healthcare US for the treatment of hypertension.

• FDA approval · 2023-07-12
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (AvKARE)

  FDA approved a supplemental application for a generic fixed-dose combination of telmisartan and hydrochlorothiazide (AvKARE) for the treatme…

• FDA approval · 2023-07-12
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for a generic valsartan and hydrochlorothiazide product manufactured by Solco Healthcare US, LLC.

• FDA approval · 2023-07-10
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Xiamen LP Pharmaceutical Co., Ltd.)

  FDA approved a supplemental ANDA for clonidine hydrochloride from Xiamen LP Pharmaceutical Co., Ltd., granting approval for a generic clonid…

• FDA approval · 2023-07-05
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) submitted by Validus Pharmaceuticals LLC.