Hypertension

• FDA approval · 2021-01-04
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for the fixed-dose combination product amlodipine and olmesartan medoxomil from Macleods Pharmac…

• FDA approval · 2021-01-04
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for a fixed-dose combination tablet of amlodipine and olmesartan medoxomil for hyperten…

• FDA approval · 2020-12-28
  FDA Approved: AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application to allow Alembic Pharmaceuticals to market a generic fixed-dose combination of amlodipine besyla…

• FDA approval · 2020-12-28
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a fixed-dose combination product of amlodipine and olmesartan medoxomil from Aurobindo Pharma Li…

• FDA approval · 2020-12-28
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Micro Labs Limited)

  The FDA approved a supplemental application for AMLODIPINE AND OLMESARTAN MEDOXOMIL from Micro Labs Limited, enabling its marketing as a fix…

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• FDA approval · 2020-12-22
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for furosemide from Marlex Pharmaceuticals, Inc., indicating an additional/or updated approval f…

• FDA approval · 2020-12-15
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …

• FDA approval · 2020-12-15
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental application for AVALIDE (irbesartan and hydrochlorothiazide) from Sanofi-Aventis U.S. LLC.

• FDA approval · 2020-12-10
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from BluePoint Laboratories.

• FDA approval · 2020-12-10
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  The FDA approved a supplemental ANDA for Triamterene and Hydrochlorothiazide from Zydus Pharmaceuticals (USA) Inc., enabling the generic pro…

• FDA approval · 2020-12-02
  FDA Approved: METOLAZONE — Original Application (Alembic Pharmaceuticals Limited)

  Alembic Pharmaceuticals Limited's original application for metolazone received FDA approval, enabling the generic version to be marketed in …

• FDA approval · 2020-11-30
  FDA Approved: IRBESARTAN — Supplemental Application (AvKARE)

  FDA approves AvKARE's supplemental application for IRBESARTAN, enabling continued marketing of the generic irbesartan product.

• FDA approval · 2020-11-27
  FDA Approved: CHLORTHALIDONE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s original application for a generic chlorthalidone product.

• FDA approval · 2020-11-25
  FDA Approved: GUANFACINE — Original Application (Slate Run Pharmaceuticals, LLC)

  FDA approved Slate Run Pharmaceuticals’ guanfacine as a generic product via an Original Application (ANDA213428).

• FDA approval · 2020-11-25
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approves a generic fixed-dose combination of atenolol and chlorthalidone for the treatment of hypertension.

• FDA approval · 2020-11-25
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Ascend Laboratories, LLC)

  FDA approved Ascend Laboratories, LLC's metoprolol succinate extended-release tablets as an original application (generic).

• FDA approval · 2020-11-18
  FDA Approved: NIFEDIPINE — Original Application (Elite Pharmaceutical Solution, Inc.)

  FDA approved the Original Application for nifedipine from Elite Pharmaceutical Solution, Inc., approving the generic nifedipine product.

• FDA approval · 2020-11-17
  FDA Approved: OLMESARTAN MEDOXOMIL — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for olmesartan medoxomil from ScieGen Pharmaceuticals, enabling marketing of a generic product.

• FDA approval · 2020-11-17
  FDA Approved: OLMESARTAN MEDOXOMIL — Supplemental Application (Lifestar Pharma LLC)

  The FDA approved a supplemental application for olmesartan medoxomil from Lifestar Pharma LLC, granting approval for this antihypertensive g…

• FDA approval · 2020-11-09
  FDA Approved: LABETALOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved LABETALOL HYDROCHLORIDE (labetalol hydrochloride) from Hikma Pharmaceuticals USA Inc. under an Original Application. The dr…

• FDA approval · 2020-11-06
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic version of metoprolol succinate (Camber Pharmaceuticals) under an Original Application (ANDA 205541).

• FDA approval · 2020-11-03
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for a generic Benazepril hydrochloride and hydrochlorothiazide combination from Sandoz Inc.

• FDA approval · 2020-11-03
  FDA Approved: NEBIVOLOL — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original ANDA for Nebivolol, a generic beta-1 blocker indicated for hypertension.

• FDA approval · 2020-10-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2020-10-15
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (Sagent Pharmaceuticals)

  The FDA approved the original application for Verapamil hydrochloride from Sagent Pharmaceuticals, establishing a generic version of this ca…