Hypertension

• FDA approval · 2024-07-11
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for propranolol hydrochloride by Lannett Company, Inc., approving changes to the existing ANDA to su…

• FDA approval · 2024-07-10
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE from Mylan Pharmaceuticals, enabling the generic…

• FDA approval · 2024-07-08
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Losartan Potassium by Quallent Pharmaceuticals Health LLC, indicating approval of an additional …

• FDA approval · 2024-07-08
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril), a generic ACE inhibitor.

• FDA approval · 2024-06-28
  FDA Approved: METOPROLOL SUCCINATE — Supplemental Application (BluePoint Laboratories)

  FDA approves a supplemental application for metoprolol succinate from BluePoint Laboratories to bring a generic version to market.

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• FDA approval · 2024-06-25
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic bisoprolol fumarate and hydrochlorothiazide combination product from Mylan Pharmac…

• FDA approval · 2024-06-17
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Bisoprolol Fumarate and Hydrochlorothiazide from ANI Pharmaceuticals, resulting in an updated ap…

• FDA approval · 2024-06-03
  FDA Approved: AMLODIPINE AND OLMESARTAN MEDOXOMIL — Supplemental Application (ScieGen Pharmaceuticals, Inc)

  The FDA approved a supplemental application for a fixed-dose combination of amlodipine and olmesartan medoxomil from ScieGen Pharmaceuticals…

• FDA approval · 2024-06-03
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the atenolol and chlorthalidone combination from Actavis Pharma, indicating regulatory approval …

• FDA approval · 2024-05-31
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application to authorize the Bisoprolol Fumarate and Hydrochlorothiazide combination tablet from Edenbridge Phar…

• FDA approval · 2024-05-31
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved a supplemental application to market a fixed-dose combination tablet of lisinopril and hydrochlorothiazide, manufactured by…

• FDA approval · 2024-05-17
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the combination product amlodipine and atorvastatin from Prasco Laboratories, enabling its conti…

• FDA approval · 2024-05-17
  FDA Approved: AMLODIPINE AND VALSARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for a generic amlodipine and valsartan combination tablet by Alembic Pharmaceuticals Limited. Th…

• FDA approval · 2024-05-09
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application to market a generic fixed-dose combination of valsartan and hydrochlorothia…

• FDA approval · 2024-05-09
  FDA Approved: DOXAZOSIN — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for doxazosin from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.). The action updates th…

• FDA approval · 2024-05-06
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for Metoprolol tartrate and hydrochlorothiazide from Alembic Pharmaceuticals Limited, a generic …

• FDA approval · 2024-04-30
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approves a supplemental application for Jubilant Cadista's generic Losartan potassium and hydrochlorothiazide product.

• FDA approval · 2024-04-30
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Accord Healthcare Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Accord Healthcare Inc. under ANDA 202556. The document does not…

• FDA approval · 2024-04-30
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for a valsartan and hydrochlorothiazide generic product from Zydus Lifesciences Limited.

• FDA approval · 2024-04-30
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by ScieGen Pharmaceuticals Inc., endorsing changes to the prod…

• FDA approval · 2024-04-23
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Original Application (FRESENIUS KABI USA, LLC)

  FDA approved the original application for Verapamil hydrochloride as a generic drug, manufactured by Fresenius Kabi USA, LLC. Verapamil hydr…

• FDA approval · 2024-04-17
  FDA Approved: NICARDIPINE HYDROCHLORIDE IN SODIUM CHLORIDE — Original Application (WG Critical Care, LLC)

  FDA approved the original ANDA for NICARDIPINE HYDROCHLORIDE IN SODIUM CHLORIDE, a generic intravenous formulation from WG Critical Care, LL…

• FDA approval · 2024-04-16
  FDA Approved: CARVEDILOL PHOSPHATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carvedilol phosphate from Sun Pharmaceutical, confirming approval of this generic salt formulati…

• FDA approval · 2024-04-11
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA granted approval of a supplemental application for valsartan and hydrochlorothiazide by Mylan Pharmaceuticals, enabling its generic prod…

• FDA approval · 2024-04-04
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Hydrochlorothiazide from Aurobindo Pharma Limited (generic).