Hypertension

• FDA approval · 2024-04-02
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved a supplemental application for a generic fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide for hypertension…

• FDA approval · 2024-04-02
  FDA Approved: FUROSEMIDE — Original Application (Devatis Inc.)

  FDA approved Devatis Inc.'s original application for a generic furosemide product, enabling its marketing in the United States.

• FDA approval · 2024-03-29
  FDA Approved: ATENOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Atenolol by Aurobindo Pharma Limited, granting approval of a generic version under the ANDA proc…

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application from Zydus Lifesciences Limited for Atenolol under ANDA 076900. This confirms approval of a gene…

• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for atenolol from Unichem Pharmaceuticals USA, Inc., granting an additional approval related to the …

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• FDA approval · 2024-03-28
  FDA Approved: ATENOLOL — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for Atenolol by Ipca Laboratories Limited.

• FDA approval · 2024-03-21
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for Hydrochlorothiazide from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-03-19
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Triamterene and Hydrochlorothiazide from Zydus Lifesciences Limited to market the generic co…

• FDA approval · 2024-03-04
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for the atenolol and chlorthalidone combination product from Unichem Pharmaceuticals (USA), Inc., ex…

• FDA approval · 2024-03-01
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for the fixed-dose combination of bisoprolol fumarate and hydrochlorothiazide from Unichem Pharm…

• FDA approval · 2024-03-01
  FDA Approved: NADOLOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Nadolol from Aurobindo Pharma Limited under ANDA201893.

• FDA approval · 2024-03-01
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Supplemental Application (Northstar Rx LLC.)

  FDA approved a supplemental application for the Atenolol and Chlorthalidone fixed-dose combination from Northstar Rx LLC.

• FDA approval · 2024-02-23
  FDA Approved: IRBESARTAN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for IRBESARTAN by Amneal Pharmaceuticals LLC.

• FDA approval · 2024-02-20
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Lupin Pharmaceuticals,Inc.)

  FDA approved a supplemental application for the fixed-dose combination of amlodipine and valsartan from Lupin Pharmaceuticals under ANDA2028…

• FDA approval · 2024-02-16
  FDA Approved: IRBESARTAN — Supplemental Application (Hisun Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for IRBESARTAN from Hisun Pharmaceuticals USA Inc., approving changes to the generic product's a…

• FDA approval · 2024-02-05
  FDA Approved: NEBIVOLOL — Supplemental Application (Modavar Pharmaceuticals LLC)

  The FDA approved Modavar Pharmaceuticals LLC's supplemental application for Nebivolol, updating the approval status of an existing Nebivolol…

• FDA approval · 2024-02-05
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approved a supplemental application for Bisoprolol Fumarate and Hydrochlorothiazide from Viona Pharmaceuticals, enabling a new generic c…

• FDA approval · 2024-02-05
  FDA Approved: NADOLOL — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Nadolol submitted by Zydus Pharmaceuticals USA Inc., resulting in updated labeling and/or indica…

• FDA approval · 2024-01-22
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application from Unichem Pharmaceuticals (USA), Inc. for valsartan (generic valsartan) under an ANDA.

• FDA approval · 2024-01-19
  FDA Approved: TERAZOSIN — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Terazosin from Bionpharma Inc., marking an update to the product's approval.

• FDA approval · 2024-01-18
  FDA Approved: BISOPROLOL FUMARATE — Original Application (Harman Finochem Limited)

  FDA approved Harman Finochem Limited's bisoprolol fumarate as an original generic application (ANDA). Bisoprolol fumarate is a beta-blocker …

• FDA approval · 2024-01-16
  FDA Approved: EDARBI — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for EDARBI (azilsartan medoxomil) submitted by Azurity Pharmaceuticals, Inc.

• FDA approval · 2024-01-10
  FDA Approved: PERINDOPRIL ERBUMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Perindopril Erbumine from Aurobindo Pharma Limited.

• FDA approval · 2024-01-10
  FDA Approved: DOXAZOSIN MESYLATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the generic doxazosin mesylate from Unichem Pharmaceuticals (USA), Inc. under an Original Abbreviated New Drug Application, for…

• FDA approval · 2024-01-08
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approves a supplemental application for Triamterene and Hydrochlorothiazide submitted by Chartwell RX, LLC.