Diabetic Nephropathy

• FDA approval · 2015-02-23
  FDA Approved: IRBESARTAN — Original Application (AvKARE)

  FDA approved AvKARE's original generic application for irbesartan (IRBESARTAN). Irbesartan is used to treat hypertension.

• FDA approval · 2015-02-13
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for Losartan Potassium from Solco Healthcare US, LLC.

• FDA approval · 2015-01-05
  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 · 2014-12-11
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for Losartan Potassium from Solco Healthcare US, LLC.

• FDA approval · 2014-12-05
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for captopril from Hikma Pharmaceuticals USA, documenting changes to the marketed captopril product …

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• FDA approval · 2014-11-05
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approves a supplemental application for losartan potassium from Micro Labs Limited.

• FDA approval · 2014-11-04
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA has granted supplemental approval for Losartan Potassium from Macleods Pharmaceuticals Limited. This action approves the supplementa…

• FDA approval · 2014-09-26
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for RAMIPRIL from Hikma Pharmaceuticals USA Inc. under ANDA077900.

• FDA approval · 2014-09-26
  FDA Approved: RAMIPRIL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for RAMIPRIL (ramipril) from Zydus Lifesciences Limited.

• FDA approval · 2014-09-25
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (AiPing Pharmaceutical, Inc.)

  FDA approved a supplemental application for Losartan Potassium from AiPing Pharmaceutical, Inc. under an ANDA, indicating an additional appr…

• FDA approval · 2014-09-25
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for a generic Losartan Potassium product from Alembic Pharmaceuticals Limited.

• FDA approval · 2014-09-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium from Quallent Pharmaceuticals Health LLC to update the approved generic p…

• FDA approval · 2014-09-21
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium submitted by Aurobindo Pharma Limited.

• FDA approval · 2014-09-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Losartan Potassium (generic), granting a supplemental approval for the prod…

• FDA approval · 2013-08-16
  FDA Approved: LISINOPRIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901))

  FDA approved a supplemental application for generic lisinopril from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals), authorizing a cha…

• FDA approval · 2013-06-11
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Losartan Potassium submitted by Aurobindo Pharma Limited.

• FDA approval · 2013-06-10
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for losartan potassium by Alembic Pharmaceuticals Limited.

• FDA approval · 2013-03-11
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for IRBESARTAN submitted by NorthStar RxLLC under an ANDA. The approval pertains to the supplemental…

• FDA approval · 2013-01-28
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approves a supplemental application for Losartan Potassium from Macleods Pharmaceuticals Limited (ANDA202230), authorizing the generic p…

• FDA approval · 2012-12-20
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium from Aurobindo Pharma Limited, resulting in approval of a generic losartan po…

• FDA approval · 2012-12-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for Losartan Potassium submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2012-12-19
  FDA Approved: LOSARTAN POTASSIUM 25 MG — Supplemental Application (Strides Pharma Science Limited)

  FDA approved the supplemental application for Losartan Potassium 25 mg by Strides Pharma Science Limited, authorizing the generic product fo…

• FDA approval · 2012-12-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA has approved Lupin Pharmaceuticals' supplemental application for Losartan Potassium, a generic product, via ANDA indicating an additiona…

• FDA approval · 2012-11-14
  FDA Approved: IRBESARTAN — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original Abbreviated New Drug Application for irbesartan, enabling a generic version of the medication.

• FDA approval · 2012-10-15
  FDA Approved: IRBESARTAN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's original ANDA for irbesartan, a generic angiotensin II receptor blocker for hypertension and …