Hypertension

• 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 · 2015-08-07
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC.

• FDA approval · 2015-07-29
  FDA Approved: NEBIVOLOL — Original Application (Ascend Laboratories, LLC)

  The FDA approved the original generic application for Nebivolol by Ascend Laboratories, LLC.

• FDA approval · 2015-07-28
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE HCT (amlodipine/valsartan/hydrochlorothiazide) from Novartis Pharmaceuticals Corporation…

• FDA approval · 2015-07-28
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXFORGE (amlodipine besilate and valsartan) from Novartis Pharmaceuticals Corporation.

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• FDA approval · 2015-07-27
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for the Bisoprolol Fumarate and Hydrochlorothiazide combination from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2015-07-22
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental NDA for Lotensin (benazepril hydrochloride) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2015-07-21
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Trandolapril (generic) under the ANDA program. This confirms regulatory cle…

• FDA approval · 2015-07-15
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC, updating the drug’s labeling as part of a …

• FDA approval · 2015-07-15
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Losartan Potassium and Hydrochlorothiazide from NorthStar Rx LLC.

• FDA approval · 2015-07-15
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved Alembic Pharmaceuticals Limited's supplemental application for a generic Losartan Potassium and Hydrochlorothiazide tablet prod…

• FDA approval · 2015-07-15
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic valsartan and hydrochlorothiazide combination product manufactured by Mylan Pharma…

• FDA approval · 2015-07-13
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for clonidine hydrochloride submitted by Solco Healthcare LLC.

• FDA approval · 2015-07-09
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approves a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) from Cosette Pharmaceuticals.

• FDA approval · 2015-07-09
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental NDA for Tenormin (atenolol) submitted by Almatica Pharma LLC, authorizing a supplemental labeling/indication…

• 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 · 2015-07-07
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approves a supplemental application for the combination drug benazepril hydrochloride and hydrochlorothiazide from Padagis US LLC.

• FDA approval · 2015-07-01
  FDA Approved: ATENOLOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Atenolol from Mylan Pharmaceuticals Inc., approving changes to the approved ANDA.

• FDA approval · 2015-06-30
  FDA Approved: QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5 — Supplemental Application (Cipla USA Inc.)

  The FDA approved Cipla USA Inc.'s supplemental application for quinapril/hydrochlorothiazide fixed-dose combinations (10/12.5, 20/12.5, 20/2…

• FDA approval · 2015-06-30
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE (Sandoz Inc), a generic benazepril hydrochlorid…

• FDA approval · 2015-06-16
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) submitted by Novartis Pharmaceuticals …

• FDA approval · 2015-06-11
  FDA Approved: ATENOLOL AND CHLORTHALIDONE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for the atenolol and chlorthalidone combination product from Actavis Pharma, Inc. This action grants…

• 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 · 2015-06-05
  FDA Approved: FUROSEMIDE — Supplemental Application (Marlex Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for furosemide from Marlex Pharmaceuticals, Inc., updating the product label.

• FDA approval · 2015-06-04
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.