Hypertension

• FDA approval · 2015-06-03
  FDA Approved: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' Original Application for a generic three-drug tablet containing amlodipine, valsartan, and hydrochloroth…

• FDA approval · 2015-06-02
  FDA Approved: NICARDIPINE HYDROCHLORIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for nicardipine hydrochloride from Civica, Inc., signaling regulatory approval of a supplement to th…

• FDA approval · 2015-06-02
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved Mylan's supplemental application for Bisoprolol Fumarate and Hydrochlorothiazide, enabling a generic product. This combinat…

• FDA approval · 2015-06-01
  FDA Approved: AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE — Original Application (Strides Pharma Science Limited)

  FDA approved Strides Pharma Science Limited's original ANDA for a fixed-dose combination of amlodipine besylate, valsartan, and hydrochlorot…

• FDA approval · 2015-05-29
  FDA Approved: CLONIDINE — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for clonidine from Dr. Reddy's Laboratories Inc., granting continued regulatory approval of a generi…

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• FDA approval · 2015-05-22
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2015-05-21
  FDA Approved: CARDENE IV — Supplemental Application (Baxter Healthcare Corporation)

  The FDA approved a supplemental application to add Cardene IV (nicardipine hydrochloride) as an intravenous formulation for use when oral th…

• FDA approval · 2015-05-18
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application (AP) for a generic fixed-dose combination of losartan potassium and hydrochlorothiazide from NorthSt…

• FDA approval · 2015-05-18
  FDA Approved: VALSARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' valsartan and hydrochlorothiazide combination via a supplemental application. This action updates the la…

• FDA approval · 2015-05-04
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental application for Trandolapril tablets from Epic Pharma, LLC, indicating regulatory approval for the requested cha…

• FDA approval · 2015-05-01
  FDA Approved: TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approves Glenmark's supplemental application for the combination drug trandolapril and verapamil hydrochloride.

• FDA approval · 2015-05-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for enalapril maleate from ScieGen Pharmaceuticals, indicating continued/expanded authorization …

• FDA approval · 2015-04-28
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for benazepril hydrochloride submitted by Aurobindo Pharma Limited under an ANDA.

• FDA approval · 2015-04-28
  FDA Approved: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Supplemental Application (Solco Healthcare US, LLC)

  The FDA approved a supplemental application for the generic fixed-dose combination of irbesartan and hydrochlorothiazide manufactured by Sol…

• FDA approval · 2015-04-26
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril hydrochloride/hydrochlorothiazide from Aurobindo Pharma Limited.

• FDA approval · 2015-04-26
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone from Mylan Pharmaceuticals Inc., indicating an approved change to an already-appr…

• FDA approval · 2015-04-24
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic Trandolapril product from Aurobindo Pharma Limited.

• FDA approval · 2015-04-22
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Lotrel (amlodipine besylate and benazepril hydrochloride) from Novartis Pharmaceuticals Corp…

• FDA approval · 2015-04-22
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for benazepril hydrochloride from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2015-04-20
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for BYSTOLIC (nebivolol hydrochloride) submitted by Allergan, Inc.

• FDA approval · 2015-04-16
  FDA Approved: EDARBYCLOR — Supplemental Application (Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals))

  FDA approved a supplemental application for EDARBYCLOR (AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE) submitted by Azurity Pharmaceuticals (for…

• FDA approval · 2015-04-16
  FDA Approved: NEBIVOLOL — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original-application Nebivolol generic, making a generic Nebivolol tablet available for the treatment …

• FDA approval · 2015-04-15
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Losartan Potassium, granting approval of a generic Losartan Potassium produ…

• 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 · 2015-04-09
  FDA Approved: LISINOPRIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for lisinopril filed by Quallent Pharmaceuticals Health LLC under ANDA 077321, enabling continued ma…