Hypertension

• FDA approval · 2019-02-07
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Original Application (Accord Healthcare Inc.)

  The FDA approved Accord Healthcare's olmesartan medoxomil and hydrochlorothiazide as an original generic combination therapy for hypertensio…

• FDA approval · 2019-02-02
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for the fixed-dose combination of irbesartan and hydrochlorothiazide from Macleods Pharmaceuticals L…

• FDA approval · 2019-01-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide from Prasco Laboratories, authorizing changes to the prod…

• FDA approval · 2019-01-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (ScieGen Pharmaceuticals Inc)

  The FDA approved ScieGen Pharmaceuticals' original application for hydrochlorothiazide, making this generic diuretic available in the United…

• FDA approval · 2019-01-07
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lotensin (benazepril hydrochloride) from Validus Pharmaceuticals LLC.

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• FDA approval · 2018-12-28
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Armas Pharmaceuticals Inc.)

  FDA approves Armas Pharmaceuticals' verapamil hydrochloride as an original ANDA generic; standard indications for verapamil HCl include hype…

• FDA approval · 2018-12-19
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Oryza Pharmaceuticals, Inc)

  The FDA approved Oryza Pharmaceuticals' generic metoprolol succinate product, an extended-release beta-blocker used to treat hypertension, a…

• FDA approval · 2018-12-13
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for irbesartan from Aurobindo Pharma Limited.

• FDA approval · 2018-12-07
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approval of AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE for the Original Application (ANDA) by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-12-04
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for candesartan cilexetil from Alembic Pharmaceuticals Limited, enabling a generic version of the anti…

• FDA approval · 2018-12-03
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approved the original application for a generic fixed-dose combination of amlodipine and olmesartan medoxomil for hypertension. The prod…

• FDA approval · 2018-11-02
  FDA Approved: IRBESARTAN — Supplemental Application (Hisun Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for IRBESARTAN by Hisun Pharmaceuticals USA Inc. The approval indicates changes related to the a…

• FDA approval · 2018-10-30
  FDA Approved: HYDRALAZINE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Hydralazine Hydrochloride (HYDRALAZINE HYDROCHLORIDE) from Nivagen Pharmaceuticals, Inc. under a…

• FDA approval · 2018-10-29
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental application for metoprolol succinate submitted by Zydus Pharmaceuticals (USA) Inc., updating the labeling fo…

• FDA approval · 2018-10-26
  FDA Approved: METOPROLOL SUCCINATE — Original Application (BluePoint Laboratories)

  FDA approved a generic metoprolol succinate product from BluePoint Laboratories under an original ANDA for the treatment of hypertension, an…

• FDA approval · 2018-10-26
  FDA Approved: FELODIPINE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' felodipine extended-release tablets under an original generic application (ANDA). The product is a…

• FDA approval · 2018-10-24
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for IRBESARTAN (irbesartan) submitted by NorthStar RxLLC.

• FDA approval · 2018-10-12
  FDA Approved: HYZAAR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for HYZAAR (losartan potassium and hydrochlorothiazide) submitted by Organon LLC.

• FDA approval · 2018-10-12
  FDA Approved: COZAAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Cozaar (losartan potassium) from Organon LLC.

• FDA approval · 2018-10-12
  FDA Approved: CHLORTHALIDONE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories Inc.'s original application for chlorthalidone (generic diuretic) under ANDA210742.

• FDA approval · 2018-10-12
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Somerset Therapeutics, LLC)

  FDA approved Somerset Therapeutics' clonidine hydrochloride as a generic drug under an Original Application. The approval supports the gener…

• FDA approval · 2018-10-03
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' original application for prazosin hydrochloride (generic), enabling its marketing as a generic treatment f…

• FDA approval · 2018-09-25
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for benazepril hydrochloride from Aurobindo Pharma Limited, enabling a generic version of the ACE in…

• FDA approval · 2018-09-14
  FDA Approved: EPLERENONE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original ANDA for eplerenone (generic), a mineralocorticoid receptor antagonist used to treat hea…

• FDA approval · 2018-09-12
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA granted supplemental approval for the fixed-dose combination of amlodipine besylate and atorvastatin calcium by Prasco Laboratories.