Hypertension

• FDA label_change · 2025-04-16
  FDA Approved: CARDIZEM CD — Supplemental Application (Bausch Health US LLC)

  FDA approves a supplemental application for Cardizem CD (diltiazem hydrochloride) by Bausch Health US LLC.

• FDA label_change · 2024-11-13
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Metoprolol Tartrate from Fresenius Kabi USA, LLC, indicating approved changes to labeling or for…

• FDA label_change · 2024-08-13
  FDA Approved: MATZIM LA — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for MATZIM LA (diltiazem hydrochloride) from Actavis Pharma, Inc. to update labeling for this long-a…

• FDA label_change · 2024-06-13
  FDA Approved: DOXAZOSIN — Supplemental Application (Upsher-Smith laboratories, LLC)

  FDA approved a supplemental application for doxazosin (doxazosin mesylate) from Upsher-Smith Laboratories, LLC. The action updates the produ…

• FDA label_change · 2024-04-30
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan and hydrochlorothiazide by Alembic Pharmaceuticals Limited, resulting in updates t…

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• FDA label_change · 2023-12-28
  FDA Approved: NEBIVOLOL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA lists a Camber Pharmaceuticals supplemental application for Nebivolol, indicating a label update under the ANDA for Nebivolol.

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

  FDA supplemental application for Losartan Potassium by Macleods Pharmaceuticals Limited, likely involving labeling changes for the generic d…

• FDA label_change · 2023-04-26
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for the telmisartan and hydrochlorothiazide combination product, updating its labeling.

• FDA label_change · 2023-03-15
  FDA Approved: IRBESARTAN — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for IRBESARTAN from Solco Healthcare U.S., LLC, indicating a labeling change for the product.

• FDA label_change · 2022-01-12
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

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

• FDA label_change · 2021-09-15
  FDA Approved: METOPROLOL — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for metoprolol tartrate products from Fresenius Kabi USA, LLC.

• FDA label_change · 2021-09-10
  FDA Approved: AVALIDE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for AVALIDE (irbesartan/hydrochlorothiazide) submitted by Sanofi-Aventis U.S. LLC.

• FDA label_change · 2021-09-10
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

  The FDA approved a supplemental labeling change for AVAPRO (irbesartan) filed by Sanofi-Aventis U.S. LLC.

• FDA label_change · 2021-04-07
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for EXFORGE (amlodipine besylate and valsartan) filed by Novartis, updating the product labeling…

• FDA label_change · 2021-02-22
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA supplemental application for EXFORGE HCT, a fixed-dose combination of amlodipine, valsartan, and hydrochlorothiazide, submitted by Novar…

• FDA label_change · 2020-08-20
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Lisinopril and Hydrochlorothiazide from Aurobindo Pharma Limited.

• FDA label_change · 2020-08-20
  FDA Approved: HYZAAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for HYZAAR (losartan potassium and hydrochlorothiazide) filed by Organon LLC, resulting in changes t…

• FDA label_change · 2020-08-14
  FDA Approved: CLONIDINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for clonidine from Ingenus Pharmaceuticals, LLC, resulting in updated labeling for the generic produ…

• FDA label_change · 2020-05-19
  FDA Approved: CAPTOPRIL — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for captopril submitted by Solco Healthcare US, LLC, updating the labeling for the generic drug …

• FDA label_change · 2020-04-08
  FDA Approved: VALSARTAN — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for valsartan from Macleods Pharmaceuticals Limited, indicating changes to the product labeling.

• FDA label_change · 2019-11-06
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the amlodipine/atorvastatin combination by Mylan Pharmaceuticals, resulting in labeling changes …

• FDA label_change · 2019-08-07
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Bisoprolol Fumarate by Unichem Pharmaceuticals (USA), Inc., resulting in a labeling change for t…

• FDA label_change · 2017-10-30
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  The FDA granted a supplemental approval for Norvasc (amlodipine besylate) filed by Viatris Specialty LLC, resulting in labeling changes.

• FDA label_change · 2017-09-14
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, typically involving a label change or n…

• FDA label_change · 2017-09-14
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, detailing changes related to the C…