Hypertension

• FDA approval · 2023-06-26
  FDA Approved: TELMISARTAN — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for a generic telmisartan product submitted by Solco Healthcare US, LLC. Telmisartan is used to …

• FDA approval · 2023-06-23
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application for spironolactone by Oxford Pharmaceuticals, LLC. The approval allows continued marketing of the ge…

• FDA approval · 2023-06-23
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for the combination drug amlodipine and olmesartan medoxomil from Ascend Laboratories, LLC.

• FDA approval · 2023-06-23
  FDA Approved: AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved a supplemental application to add a fixed-dose combination of amlodipine besylate and olmesartan medoxomil from Ajanta Pharma U…

• FDA approval · 2023-06-16
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for BYSTOLIC (nebivolol hydrochloride) submitted by Allergan, Inc.

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• FDA approval · 2023-06-12
  FDA Approved: METOPROLOL SUCCINATE — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved the Original Application (ANDA216916) for Metoprolol succinate, a generic version manufactured by Granules Pharmaceuticals Inc.

• FDA approval · 2023-06-09
  FDA Approved: TELMISARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for TELMISARTAN from Aurobindo Pharma Limited, authorizing a generic telmisartan product.

• FDA approval · 2023-06-08
  FDA Approved: TELMISARTAN — Supplemental Application (Micro Labs Limited)

  The FDA approved a supplemental application for Telmisartan from Micro Labs Limited under an ANDA. This indicates a supplemental approval fo…

• FDA approval · 2023-06-07
  FDA Approved: CANDESARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for candesartan by Macleods Pharmaceuticals Limited, enabling the marketed generic candesartan produ…

• FDA approval · 2023-06-07
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Losartan potassium and hydrochlorothiazide from Macleods Pharmaceuticals Limited, authorizing a …

• FDA approval · 2023-06-02
  FDA Approved: OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for a generic fixed-dose combination of olmesartan medoxomil, amlodipine besylate, and hydrochlo…

• FDA approval · 2023-06-02
  FDA Approved: EPLERENONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' Original Application for a generic version of eplerenone (Inspra).

• FDA approval · 2023-06-02
  FDA Approved: NADOLOL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Nadolol under an Original Application from Alembic Pharmaceuticals Limited, authorizing a generic Nadolol product.

• FDA approval · 2023-06-01
  FDA Approved: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE — Original Application (NorthStar RxLLC)

  The FDA approved the original application for a generic fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide. This enables…

• FDA approval · 2023-05-31
  FDA Approved: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)

  FDA supplemental approval for a generic fixed-dose combination of amlodipine besylate and atorvastatin calcium by Dr. Reddy's Laboratories I…

• FDA approval · 2023-05-26
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved Alembic Pharmaceuticals Limited's supplemental application for a generic Metoprolol Tartrate and Hydrochlorothiazide produc…

• FDA approval · 2023-05-26
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for metoprolol succinate from BluePoint Laboratories, allowing continued manufacture of the gene…

• FDA approval · 2023-05-19
  FDA Approved: ALISKIREN — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for aliskiren (Tekturna) submitted by Endo USA, Inc.

• FDA approval · 2023-05-17
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sun Pharmaceutical's spironolactone and hydrochlorothiazide combination product. The submission …

• FDA approval · 2023-05-10
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2023-05-09
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for a generic Metoprolol Succinate product from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-05-05
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for metoprolol succinate from Zydus Pharmaceuticals (USA) Inc., approving its generic product under …

• FDA approval · 2023-05-01
  FDA Approved: TELMISARTAN — Supplemental Application (Chartwell RX, LLC.)

  The FDA approved a supplemental application for Telmisartan submitted by Chartwell RX, LLC.

• FDA approval · 2023-05-01
  FDA Approved: NIFEDIPINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for nifedipine from Ingenus Pharmaceuticals, LLC, for an already approved generic nifedipine product…

• FDA approval · 2023-04-25
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for a metoprolol tartrate and hydrochlorothiazide combination product from Sun Pharmaceutical Indust…