Hypertension

• FDA approval · 2010-08-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for verapamil hydrochloride from Mylan Pharmaceuticals Inc., granting/confirming approval for a …

• FDA approval · 2010-08-04
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for aliskiren hemifumarate submitted by Prasco Laboratories.

• FDA approval · 2010-07-30
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Quinapril Hydrochloride/Hydrochlorothiazide from Aurobindo Pharma Limited, authorizing the marke…

• FDA approval · 2010-07-30
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for trandolapril, enabling the marketing of a generic formulation. This act…

• FDA approval · 2010-07-28
  FDA Approved: DURACLON — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for DURACLON (clonidine hydrochloride) submitted by Mylan Institutional LLC. This action confirms ap…

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• FDA approval · 2010-07-28
  FDA Approved: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a generic combination tablet of bisoprolol fumarate and hydrochlorothiazide for hypertension, manufactured by Unichem Pharmaceu…

• FDA approval · 2010-07-23
  FDA Approved: TRIBENZOR — Original Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved Cosette Pharmaceuticals' original application for Tribenzor, a triple combination antihypertensive therapy consisting of ol…

• FDA approval · 2010-07-16
  FDA Approved: CLONIDINE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved a generic clonidine product from Mylan Pharmaceuticals via an Original Application (ANDA).

• FDA approval · 2010-07-06
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for atenolol submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2010-07-02
  FDA Approved: SPIRONOLACTONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's original application for generic spironolactone, establishing a bioequivalent product to the refer…

• FDA approval · 2010-06-30
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for amlodipine besylate by Aurobindo Pharma Limited as a generic product.

• FDA approval · 2010-06-23
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for clonidine hydrochloride from Actavis Pharma, Inc. under ANDA070976.

• FDA approval · 2010-06-15
  FDA Approved: DOXAZOSIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for doxazosin mesylate filed by Teva Pharmaceuticals USA, Inc. under ANDA075536.

• FDA approval · 2010-06-04
  FDA Approved: METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the generic fixed-dose combination of metoprolol tartrate and hydrochlorothiazide, manufactured …

• FDA approval · 2010-06-04
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application from Dr. Reddy's Laboratories Limited for a fixed-dose combination tablet of amlodipine besylate and…

• FDA approval · 2010-05-27
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for clonidine hydrochloride from Solco Healthcare LLC, approving the generic product's submission.

• FDA approval · 2010-05-26
  FDA Approved: TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a generic fixed-dose combination of trandolapril and verapamil hydrochloride (ANDA) from Glenmark Pharmaceuticals for the t…

• FDA approval · 2010-05-21
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original generic application for a fixed-dose combination tablet of losartan potassium and hydrochlo…

• FDA approval · 2010-05-11
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amlodipine besylate from Zydus Pharmaceuticals USA Inc., granting approval for the generic produ…

• FDA approval · 2010-05-10
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (TruPharma, LLC)

  The FDA approved a supplemental application for clonidine hydrochloride from TruPharma, LLC, as part of an existing ANDA.

• FDA approval · 2010-05-07
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' lisinopril supplemental application (ANDA 075903), making a generic lisinopril tablet available with ap…

• FDA approval · 2010-05-05
  FDA Approved: TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic fixed-dose combination of trandolapril and verapamil hydrochloride via an Original Application (ANDA).

• FDA approval · 2010-04-30
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Supplemental Application (Oxford Pharmaceuticals, LLC)

  FDA approved a supplemental application to allow amlodipine besylate 2.5 mg as an additional dosage strength for Oxford Pharmaceuticals' pro…

• FDA approval · 2010-04-28
  FDA Approved: CATAPRES-TTS-1 — Supplemental Application (Technomed Inc.)

  The FDA approved a supplemental application for CATAPRES-TTS-1, the clonidine transdermal system, from Technomed Inc.

• FDA approval · 2010-04-21
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Diovan HCT (valsartan and hydrochlorothiazide) from Novartis Pharmaceuticals. This approval …