Hypertension

• FDA label_change · 2011-05-09
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Norvasc (amlodipine besylate) filed by Viatris Specialty LLC. This action updates the produc…

• FDA label_change · 2011-03-15
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for hydrochlorothiazide, resulting in changes to the product labeling.

• FDA label_change · 2009-12-22
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA overview of a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) submitted by Novartis, likely invol…

• FDA label_change · 2009-11-06
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) submitted by Almatica Pharma Inc. The supplement…

• FDA label_change · 2009-10-28
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) by Novartis Pharmaceuticals Corporatio…

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• FDA label_change · 2009-08-31
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Sandoz Inc.'s benazepril hydrochloride and hydrochlorothiazide fixed-dose combination (ANDA 0766…

• FDA label_change · 2009-08-11
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental labeling application for Micardis HCT (telmisartan/hydrochlorothiazide).

• FDA label_change · 2009-08-11
  FDA Approved: MICARDIS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA has approved a supplemental application for MICARDIS (telmisartan) filed by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA label_change · 2009-05-20
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  The FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) from Almatica Pharma Inc., resulting in chan…

• FDA label_change · 2008-09-25
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) submitted by Bausch Health US, LLC, reflec…

• FDA label_change · 2008-08-14
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Amici Pharma, Inc)

  FDA approved a supplemental application for enalapril maleate from Amici Pharma, Inc., resulting in labeling changes for the product.

• FDA label_change · 2008-07-31
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) submitted by Novartis, reflecting a labeling update f…

• FDA label_change · 2008-05-29
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA Supplemental Application for Lotensin (benazepril hydrochloride) submitted by Validus Pharmaceuticals LLC.

• FDA label_change · 2007-10-31
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for NORVASC (amlodipine besylate) by Viatris Specialty LLC, resulting in changes to the labeling…

• FDA label_change · 2007-09-26
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Benicar (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.

• FDA label_change · 2007-08-31
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) to update the product labeling.

• FDA label_change · 2007-07-16
  FDA Approved: ZESTORETIC — Supplemental Application (Almatica Pharma Inc.)

  FDA approved a supplemental application for ZESTORETIC (lisinopril and hydrochlorothiazide) from Almatica Pharma Inc.

• FDA label_change · 2007-03-14
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for TOPROL XL (metoprolol succinate) submitted by Melinta Therapeutics, LLC.

• FDA label_change · 2007-02-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc., resulting in labe…

• FDA label_change · 2006-12-20
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC. The approval indicates an update to…

• FDA label_change · 2006-11-20
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) submitted by Novartis, updating the product labeling.

• FDA label_change · 2006-08-28
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the fixed-dose combination of amlodipine and atorvastatin from Prasco Laboratories, resulting in…