Diabetic Nephropathy

• FDA approval · 2021-04-30
  FDA Approved: CANDESARTAN CILEXETIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for candesartan cilexetil from Mylan Pharmaceuticals Inc.

• FDA approval · 2021-04-23
  FDA Approved: IRBESARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for Irbesartan from Unichem Pharmaceuticals USA, Inc., indicating regulatory approval of a modif…

• FDA approval · 2020-11-30
  FDA Approved: IRBESARTAN — Supplemental Application (AvKARE)

  FDA approves AvKARE's supplemental application for IRBESARTAN, enabling continued marketing of the generic irbesartan product.

• FDA approval · 2020-10-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2020-04-27
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC, approving a generic lisinopril product.

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• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL (captopril) from Hikma Pharmaceuticals USA Inc. under an ANDA. The action concerns…

• FDA approval · 2019-11-06
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for IRBESARTAN from Camber Pharmaceuticals, Inc., approving changes related to this product's use or…

• FDA approval · 2019-11-06
  FDA Approved: VALSARTAN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for valsartan from Ascend Laboratories, updating the regulatory status of this generic antihypertens…

• FDA approval · 2019-08-20
  FDA Approved: VALSARTAN — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for VALSARTAN submitted by Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2019-08-16
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Irbesartan from Camber Pharmaceuticals, indicating an approved change to the existing ANDA a…

• FDA approval · 2019-08-07
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approves a supplemental application for enalapril maleate by Taro Pharmaceuticals U.S.A., Inc., pertaining to an approved product (gener…

• FDA approval · 2019-07-05
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals' supplemental application for Losartan Potassium Tablets, 25 mg, under ANDA201170.

• FDA approval · 2019-05-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Losartan Potassium from Unichem Pharmaceuticals (USA), Inc., authorizing the marketing of a gene…

• FDA approval · 2019-05-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  Supplemental application for Losartan Potassium from Micro Labs Limited has been approved by the FDA.

• FDA approval · 2019-04-23
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Irbesartan (ANDA).

• FDA approval · 2018-11-02
  FDA Approved: IRBESARTAN — Supplemental Application (Hisun Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for IRBESARTAN by Hisun Pharmaceuticals USA Inc. The approval indicates changes related to the a…

• FDA approval · 2018-10-24
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for IRBESARTAN (irbesartan) submitted by NorthStar RxLLC.

• FDA approval · 2018-10-12
  FDA Approved: COZAAR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Cozaar (losartan potassium) from Organon LLC.

• FDA approval · 2018-08-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  FDA approved a supplemental application for enalapril maleate from Oceanside Pharmaceuticals, indicating an updated/expanded labeling for th…

• FDA approval · 2018-07-20
  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 · 2018-04-09
  FDA Approved: VALSARTAN — Original Application (SQUARE PHARMACEUTICALS LIMITED)

  The FDA approved Square Pharmaceuticals Limited's original application for valsartan (generic valsartan).

• FDA approval · 2017-07-21
  FDA Approved: ZESTRIL — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for ZESTRIL (lisinopril) submitted by Upsher-Smith Laboratories.

• FDA approval · 2017-04-12
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved Solco Healthcare US, LLC's supplemental application for Losartan Potassium, a generic product, enabling its continued marke…

• FDA approval · 2016-12-06
  FDA Approved: IRBESARTAN — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's supplemental application for IRBESARTAN, enabling the generic ARB formulation to be marketed …

• FDA approval · 2016-11-16
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for Losartan Potassium, marking an approval of changes to the generic pr…