Diabetic Nephropathy

• FDA approval · 2016-09-13
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for lisinopril submitted by Aurobindo Pharma Limited under ANDA 077622.

• FDA approval · 2016-08-22
  FDA Approved: IRBESARTAN — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approved a supplemental application for IRBESARTAN from Solco Healthcare U.S., LLC.

• FDA approval · 2016-08-09
  FDA Approved: IRBESARTAN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for IRBESARTAN, a generic irbesartan product.

• FDA approval · 2016-08-09
  FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

  FDA approved a supplemental application for IRBESARTAN by NorthStar RxLLC, approving an update to the already approved generic product.

• FDA approval · 2016-06-14
  FDA Approved: IRBESARTAN — Original Application (Hisun Pharmaceuticals USA Inc.)

  FDA approved the original application for IRBESARTAN (generic irbesartan) by Hisun Pharmaceuticals USA Inc., marking approval of the generic…

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• FDA approval · 2016-06-10
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for losartan potassium submitted by Alembic Pharmaceuticals Limited (ANDA 090428). This action u…

• FDA approval · 2016-06-10
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved Jubilant Cadista Pharmaceuticals Inc. to market Losartan potassium tablets, 25 mg, as a generic product under an ANDA supplemen…

• FDA approval · 2016-06-10
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' supplemental application for losartan potassium (generic), confirming an approved generic product.

• FDA approval · 2016-06-09
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Losartan Potassium (generic) from Lupin Pharmaceuticals, Inc.

• FDA approval · 2016-02-28
  FDA Approved: RAMIPRIL — Supplemental Application (Chartwell RX, LLC.)

  The FDA has approved a supplemental application for RAMIPRIL, allowing Chartwell RX, LLC to market a RAMIPRIL generic product.

• FDA approval · 2016-02-24
  FDA Approved: LISINOPRIL — Supplemental Application (Solco healthcare U.S., LLC)

  The FDA approved a supplemental application for lisinopril from Solco Healthcare U.S., LLC.

• FDA approval · 2016-02-23
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2016-02-18
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Northstar RxLLC)

  FDA approved a supplemental application for Enalapril Maleate from Northstar RxLLC under an ANDA.

• FDA approval · 2016-02-16
  FDA Approved: RAMIPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Ramipril (generic ACE inhibitor) under ANDA 077626, enabling a generic …

• FDA approval · 2016-02-05
  FDA Approved: AVAPRO — Supplemental Application (Sanofi-Aventis U.S. LLC)

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

• FDA approval · 2015-12-07
  FDA Approved: IRBESARTAN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original ANDA for Irbesartan, a generic angiotensin II receptor blocker. The approval allows Camber to …

• FDA approval · 2015-11-17
  FDA Approved: IRBESARTAN — Supplemental Application (Solco Healthcare U.S., LLC)

  FDA approves a supplemental application for IRBESARTAN submitted by Solco Healthcare U.S., LLC.

• FDA approval · 2015-10-26
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Alembic Pharmaceuticals Limited)

  The FDA approved a supplemental application for losartan potassium from Alembic Pharmaceuticals Limited under the ANDA.

• FDA approval · 2015-10-15
  FDA Approved: IRBESARTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for IRBESARTAN (irbesartan), indicating an approved change to the generic p…

• FDA approval · 2015-10-14
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original application for a generic losartan potassium tablet by Unichem Pharmaceuticals (USA), Inc. for hypertension and re…

• FDA approval · 2015-08-12
  FDA Approved: LOSARTAN POTASSIUM — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' original generic application for losartan potassium, a generic version of the hypertension medication l…

• FDA approval · 2015-07-07
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Losartan Potassium tablets from Aurobindo Pharma Limited (ANDA 090083). This is an approval of a…

• FDA approval · 2015-06-09
  FDA Approved: VALSARTAN — Original Application (Solco Healthcare US, LLC)

  FDA approved the original ANDA for valsartan (generic) submitted by Solco Healthcare US, LLC, authorizing marketing of this ARB for hyperten…

• FDA approval · 2015-04-10
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application for Jubilant Cadista's Losartan Potassium Tablets, 25 mg, supporting the approval of this generic do…

• FDA approval · 2015-03-31
  FDA Approved: LOSARTAN POTASSIUM TABLETS, 25 MG — Supplemental Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a supplemental application to add a 25 mg strength of Losartan Potassium Tablets, expanding the product's dosage options. The a…