Hypertension

• FDA approval · 2011-12-12
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA approved a supplemental application for amlodipine besylate and benazepril hydrochloride tablets by Dr. Reddy's Laboratories, expanding …

• FDA approval · 2011-12-12
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Dr.Reddy's Laboratories Limited)

  FDA supplemental approval for amlodipine besylate and benazepril hydrochloride, a combination antihypertensive, submitted by Dr. Reddy's Lab…

• FDA approval · 2011-12-12
  FDA Approved: DIOVAN HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Diovan HCT (valsartan/hydrochlorothiazide) submitted by Novartis Pharmaceuticals Corporation…

• FDA approval · 2011-12-09
  FDA Approved: TRIAMTERENE AND HYDROCHLOROTHIAZIDE — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for the generic fixed-dose combination triamterene/hydrochlorothiazide.

• FDA approval · 2011-12-07
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approves a supplemental application for EXFORGE (amlodipine besylate and valsartan) from Novartis Pharmaceuticals Corporation. The actio…

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• FDA approval · 2011-12-07
  FDA Approved: EXFORGE HCT — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) submitted by Novartis Pharmaceuticals…

• FDA approval · 2011-12-06
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals' clonidine hydrochloride original application, providing a generic version of the antihypertensive agen…

• FDA approval · 2011-11-29
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Chartwell RX, LLC.

• FDA approval · 2011-11-29
  FDA Approved: MOEXIPRIL HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental application for Moexipril hydrochloride from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2011-11-28
  FDA Approved: ATENOLOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for generic atenolol from Rising Pharma Holdings, Inc. under the ANDA.

• FDA approval · 2011-11-28
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril Hydrochloride/Hydrochlorothiazide from Aurobindo Pharma Limited, granting approval of …

• FDA approval · 2011-11-28
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for spironolactone filed by Amneal Pharmaceuticals LLC, a generic product. The approval confirms cha…

• FDA approval · 2011-11-28
  FDA Approved: FELODIPINE — Original Application (Torrent Pharmaceuticals Limited)

  The FDA approved Torrent Pharmaceuticals Limited's felodipine generic tablet under an Original Application (ANDA 202170). Felodipine is a ca…

• FDA approval · 2011-11-15
  FDA Approved: MOEXIPRIL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Moexipril Hydrochloride by Teva Pharmaceuticals USA, Inc. Moexipril Hydrochloride is an ACE inhi…

• FDA approval · 2011-11-14
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for AZOR, a fixed-dose combination of amlodipine besylate and olmesartan medoxomil, submitted by Cos…

• FDA approval · 2011-11-14
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals Inc)

  FDA approved a supplemental application for Verapamil hydrochloride submitted by Teva Pharmaceuticals Inc. This action finalizes changes to …

• FDA approval · 2011-11-14
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for hydrochlorothiazide submitted by Exelan Pharmaceuticals Inc.

• FDA approval · 2011-11-02
  FDA Approved: AZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AZOR (amlodipine besylate and olmesartan medoxomil) submitted by Cosette Pharmaceuticals, In…

• FDA approval · 2011-11-02
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (EXELA PHARMA SCIENCES, LLC)

  FDA approved a supplemental NDA for Verapamil Hydrochloride from Exela Pharma Sciences, LLC under NDA 018925.

• FDA approval · 2011-11-01
  FDA Approved: TRIBENZOR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Tribenzor (olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide) submitted by Cosett…

• FDA approval · 2011-10-31
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Norvasc (amlodipine besylate) submitted by Viatris Specialty LLC, resulting in an approved label…

• FDA approval · 2011-10-28
  FDA Approved: CARTIA XT — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma, Inc.'s supplemental application for CARTIA XT (diltiazem hydrochloride) under ANDA074752.

• FDA approval · 2011-10-28
  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 · 2011-10-28
  FDA Approved: FELODIPINE — Original Application (Endo USA, Inc.)

  FDA approves Endo USA, Inc.'s original application for Felodipine (generic), a calcium channel blocker for hypertension and angina.

• FDA approval · 2011-10-27
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for a generic Losartan Potassium and Hydrochlorothiazide product manufactured by Teva Pharmaceutical…