Hypertension

• 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 · 2016-06-09
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Losartan Potassium from Micro Labs Limited, granting a supplemental approval for this generic pr…

• FDA approval · 2016-06-09
  FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for doxazosin from Mylan Pharmaceuticals, indicating a labeling or formulation update to the existin…

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• FDA approval · 2016-06-09
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for Losartan Potassium from Macleods Pharmaceuticals Limited under ANDA 202230, enabling marketing o…

• FDA approval · 2016-06-03
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for the combination drug benazepril hydrochloride and hydrochlorothiazide submitted by Padagis U…

• FDA approval · 2016-05-24
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  The FDA approved a supplemental application for Enalapril Maleate and Hydrochlorothiazide from Taro Pharmaceuticals U.S.A., Inc. This supple…

• FDA approval · 2016-05-20
  FDA Approved: NISOLDIPINE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for nisoldipine by Prasco Laboratories.

• FDA approval · 2016-05-13
  FDA Approved: BENICAR HCT — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) by Cosette Pharmaceuticals, Inc.

• FDA approval · 2016-05-04
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for eplerenone from Mylan Pharmaceuticals, updating the approved product label for this generic …

• FDA approval · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol filed by Advagen Pharma Ltd, resulting in an additional authorization for the product…

• FDA approval · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for carvedilol (CARVEDILOL).

• FDA approval · 2016-04-22
  FDA Approved: AMLODIPINE AND VALSARTAN — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for a generic fixed-dose combination of amlodipine and valsartan by Aurobindo Pharma Limited.

• FDA approval · 2016-04-12
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, Inc. (ANDA 075178).

• FDA approval · 2016-04-04
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for carvedilol from Aurobindo Pharma Limited, enabling continued market supply of this generic produ…

• FDA approval · 2016-03-31
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for irbesartan and hydrochlorothiazide combination tablets from Aurobindo Pharma Limited.

• FDA approval · 2016-03-29
  FDA Approved: TELMISARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals' supplemental application for a generic fixed-dose combination of telmisartan and hydrochlorothiazide.

• FDA approval · 2016-03-24
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for the benazepril hydrochloride and hydrochlorothiazide combination from Sandoz Inc.

• FDA approval · 2016-03-24
  FDA Approved: TELMISARTAN — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for telmisartan submitted by Ascend Laboratories, LLC, authorizing the marketing of a generic telmis…

• FDA approval · 2016-03-21
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2016-03-21
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' supplemental application for carvedilol, clearing a generic formulation for regulatory sale. This…

• FDA approval · 2016-03-08
  FDA Approved: FUROSEMIDE — Supplemental Application (Phlow Corporation)

  FDA approved a supplemental application for furosemide submitted by Phlow Corporation.

• FDA approval · 2016-03-07
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for hydrochlorothiazide filed by Exelan Pharmaceuticals Inc. (ANDA).

• FDA approval · 2016-03-04
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for LASIX (furosemide) submitted by Validus Pharmaceuticals LLC.