Hypertension

• FDA approval · 2024-10-01
  FDA Approved: NEBIVOLOL — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved Nebivolol under an Original Application (ANDA) from Novadoz Pharmaceuticals LLC, resulting in a generic product for hypertensio…

• FDA approval · 2024-09-27
  FDA Approved: DOXAZOSIN — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for doxazosin, a generic product, likely updating labeling or manufacturing detail…

• FDA approval · 2024-09-25
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' supplemental application for metoprolol tartrate (metoprolol) under ANDA 202871, enabling a generic ve…

• FDA approval · 2024-09-24
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for carvedilol by Sandoz Inc. This is a supplemental approval for a generic carvedilol product.

• FDA approval · 2024-09-24
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Cipla USA Inc.)

  FDA approved Cipla USA Inc.'s generic nicardipine hydrochloride (ANDA Original Application). Nicardipine hydrochloride is a calcium channel …

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• FDA approval · 2024-09-23
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Supplemental Application (MARLEX PHARMACEUTICALS, INC)

  The FDA approved a supplemental application for Atenolol and Chlorthalidone tablets from Marlex Pharmaceuticals, expanding the availability …

• FDA approval · 2024-09-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide from Teva Pharmaceuticals USA, Inc. The approval concerns regulatory changes…

• FDA approval · 2024-09-19
  FDA Approved: ENALAPRIL MALEATE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the generic enalapril maleate from Rising Pharma Holdings under an Original Application (ANDA 218531).

• FDA approval · 2024-09-17
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved the original ANDA for prazosin hydrochloride as a generic product from Novadoz Pharmaceuticals LLC for the treatment of hyperte…

• FDA approval · 2024-09-12
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for diltiazem hydrochloride by Mylan Pharmaceuticals Inc. under ANDA074910, indicating regulatory ap…

• FDA approval · 2024-09-09
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride (Hospira, Inc.), confirming it as an approved generic drug under an ANDA…

• FDA approval · 2024-09-06
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Original Application (Chengdu Shuode Pharmaceutical Co., Ltd)

  FDA approved nicardipine hydrochloride as an original-application product from Chengdu Shuode Pharmaceutical Co., Ltd.

• FDA approval · 2024-08-27
  FDA Approved: NEBIVOLOL — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Nebivolol submitted by Ascend Laboratories, LLC.

• FDA approval · 2024-08-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol (generic), indicating regulatory approval related to t…

• FDA approval · 2024-08-23
  FDA Approved: INDAPAMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Indapamide submitted by Rising Pharma Holdings, Inc., under the ANDA.

• FDA approval · 2024-08-21
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Hydralazine hydrochloride under an Original Application (ANDA) submitted by Macleods Pharmaceuticals Limited.

• FDA approval · 2024-08-19
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Labetalol Hydrochloride from Hikma Pharmaceuticals USA Inc., approving changes to the produc…

• FDA approval · 2024-08-08
  FDA Approved: NEBIVOLOL — Supplemental Application (Apnar Pharma LP)

  The FDA approved a supplemental application for nebivolol hydrochloride submitted by Apnar Pharma LP (ANDA216568).

• FDA approval · 2024-07-29
  FDA Approved: TEZRULY — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved TEZRULY (terazosin) under ANI Pharmaceuticals' original NDA, bringing terazosin to market under a new brand for approved in…

• FDA approval · 2024-07-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza pharmaceuticals Inc.)

  FDA approved a generic metoprolol succinate product from Oryza Pharmaceuticals Inc. via an Original Application (ANDA).

• FDA approval · 2024-07-22
  FDA Approved: VALSARTAN — Original Application (Zydus Lifesciences Limited)

  FDA granted original approval for VALSARTAN (Valsartan) by Zydus Lifesciences Limited as a generic product under ANDA 218991.

• FDA approval · 2024-07-16
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) from Actavis Pharma, Inc.

• FDA approval · 2024-07-15
  FDA Approved: NADOLOL — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Nadolol from Amneal Pharmaceuticals NY LLC under ANDA 208832, confirming the continued approval …

• FDA approval · 2024-07-11
  FDA Approved: NADOLOL — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Nadolol from Alembic Pharmaceuticals Limited, expanding access to this generic beta-blocker.

• FDA approval · 2024-07-11
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide for hypertension under ANDA 207037, manufactur…