Diabetic Nephropathy

• FDA approval · 2026-02-18
  FDA Approved: ARBLI — Supplemental Application (Scienture LLC)

  FDA approved a supplemental application for ARBLI (losartan potassium) filed by Scienture LLC.

• FDA approval · 2025-12-16
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Camber Pharmaceuticals' Losartan Potassium (generic Losartan Potassium). The approval authorizes…

• FDA approval · 2025-11-25
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for irbesartan filed by NorthStar RxLLC under ANDA 202254, authorizing changes to the product's appr…

• FDA approval · 2025-11-12
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for IRBESARTAN (irbesartan) from Aurobindo Pharma Limited. This action approves changes under the AN…

• FDA approval · 2025-09-30
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for IRBESARTAN submitted by Camber Pharmaceuticals, Inc.

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• FDA approval · 2025-08-01
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

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

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

• FDA approval · 2024-02-16
  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 · 2023-08-23
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for losartan potassium from Micro Labs Limited under an ANDA, indicating an update to the drug's app…

• FDA approval · 2023-08-14
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approves the original application for losartan potassium (a generic product) by Novadoz Pharmaceuticals LLC.

• FDA approval · 2022-11-01
  FDA Approved: IRBESARTAN — Supplemental Application (AvKARE)

  FDA approved AvKARE's supplemental application for IRBESARTAN (irbesartan).

• FDA approval · 2022-07-14
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Losartan Potassium by Camber Pharmaceuticals, enabling the marketing of a generic Losartan P…

• FDA approval · 2022-07-01
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium from Aurobindo Pharma Limited, authorizing changes to the approved ANDA.

• FDA approval · 2021-12-20
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Irbesartan from Aurobindo Pharma Limited.

• FDA approval · 2021-12-20
  FDA Approved: IRBESARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for IRBESARTAN from Unichem Pharmaceuticals (USA), Inc. for this generic product (ANDA 203020).

• FDA approval · 2021-12-08
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for irbesartan from NorthStar RxLLC, authorizing changes to an existing generic product under an…

• FDA approval · 2021-12-06
  FDA Approved: VALSARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for valsartan submitted by Aurobindo Pharma Limited, updating the existing approval for this generic…

• FDA approval · 2021-12-03
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for irbesartan submitted by Lupin Pharmaceuticals, Inc.

• FDA approval · 2021-09-14
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for IRBESARTAN, a generic angiotensin II receptor blocker.

• FDA approval · 2021-09-01
  FDA Approved: IRBESARTAN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for IRBESARTAN from Aurobindo Pharma Limited under ANDA 203081.

• FDA approval · 2021-08-26
  FDA Approved: IRBESARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for IRBESARTAN filed by Unichem Pharmaceuticals (USA), Inc., effectively updating the existing A…

• FDA approval · 2021-08-05
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for enalaprilate maleate from Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effecti…

• FDA approval · 2021-05-06
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for IRBESARTAN by NorthStar RxLLC, indicating an update to the label or expanded indication.

• FDA approval · 2021-05-06
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for IRBESARTAN from Camber Pharmaceuticals for the generic irbesartan product, indicating an approve…