Hypertension

• FDA approval · 2019-05-03
  FDA Approved: FUROSEMIDE — Original Application (Eugia US LLC)

  FDA approved an original ANDA for FUROSEMIDE by Eugia US LLC, confirming a generic version of the diuretic. This is a routine generic drug a…

• FDA approval · 2019-04-29
  FDA Approved: FELODIPINE — Original Application (Carlsbad Technology, Inc.)

  FDA approved Felodipine through an original application filed by Carlsbad Technology, Inc., for treatment of hypertension. Felodipine is als…

• FDA approval · 2019-04-25
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for IRBESARTAN AND HYDROCHLOROTHIAZIDE, a generic fixed‑dose combination by Alembic Pharmaceuticals …

• FDA approval · 2019-04-23
  FDA Approved: TELMISARTAN — Supplemental Application (Chartwell RX, LLC.)

  The FDA approved a supplemental application to authorize a generic telmisartan product from Chartwell RX, LLC. Telmisartan is used to treat …

• FDA approval · 2019-04-23
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Irbesartan (ANDA).

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• FDA approval · 2019-04-23
  FDA Approved: IRBESARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for IRBESARTAN from Amneal Pharmaceuticals LLC.

• FDA approval · 2019-04-16
  FDA Approved: TELMISARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for telmisartan from Alembic Pharmaceuticals Limited, indicating regulatory approval of changes to t…

• FDA approval · 2019-04-16
  FDA Approved: TELMISARTAN — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Telmisartan submitted by Zydus Lifesciences Limited.

• FDA approval · 2019-04-04
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from NorthStar Rx LLC.

• FDA approval · 2019-04-04
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Hisun Pharmaceuticals USA, Inc.)

  The FDA approved the Original Application for Losartan Potassium from Hisun Pharmaceuticals USA, enabling the marketing of a generic losarta…

• FDA approval · 2019-04-02
  FDA Approved: TELMISARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Telmisartan from Aurobindo Pharma Limited.

• FDA approval · 2019-04-02
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for benazepril hydrochloride from Aurobindo Pharma Limited, indicating an update to an already appro…

• FDA approval · 2019-03-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for propranolol hydrochloride (generic propranolol HCl).

• FDA approval · 2019-03-22
  FDA Approved: ALISKIREN — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original ANDA for aliskiren, a generic renin inhibitor used to treat hypertension.

• FDA approval · 2019-03-15
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original ANDA for a generic fixed-dose combination of valsartan and hydrochlorothiazide manufactured by Zydus Lifesciences …

• FDA approval · 2019-03-12
  FDA Approved: VALSARTAN — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for valsartan from Ascend Laboratories, making a generic ARB available. It covers indications includin…

• FDA approval · 2019-03-12
  FDA Approved: NIFEDIPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approves Ingenus Pharmaceuticals' generic nifedipine under an Original Application (ANDA210614). The approved product is indicated for h…

• FDA approval · 2019-03-08
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Original Application (Northstar Rx LLC.)

  FDA approved Northstar Rx LLC's generic combination tablet of atenolol and chlorthalidone for hypertension under an original ANDA.

• FDA approval · 2019-03-06
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for carvedilol (generic). The action confirms regulatory approval…

• FDA approval · 2019-03-05
  FDA Approved: CLONIDINE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved Ingenus Pharmaceuticals' original abbreviated new drug application for clonidine, authorizing a generic clonidine product.

• FDA approval · 2019-03-04
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Original Application (AvKARE)

  The FDA approved AvKARE's generic fixed-dose combination of telmisartan and hydrochlorothiazide for the treatment of hypertension.

• FDA approval · 2019-02-26
  FDA Approved: CHLORTHALIDONE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original application for chlorthalidone, a generic diuretic. This enables marketing of the generic chlo…

• FDA approval · 2019-02-22
  FDA Approved: OLMESARTAN MEDOXOMIL — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for olmesartan medoxomil tablets, establishing a generic version of the antihypertensive medi…

• FDA approval · 2019-02-19
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Hisun Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Irbesartan and Hydrochlorothiazide by Hisun Pharmaceuticals USA Inc., updating the product's lab…

• FDA approval · 2019-02-11
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for a generic Triamterene and Hydrochlorothiazide tablet from Zydus Lifesciences Limited.