Hypertension

• FDA approval · 2010-04-15
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approves the original application for Amlodipine Besylate and Benazepril Hydrochloride from Dr.Reddy's Laboratories Limited for hyperten…

• FDA approval · 2010-04-13
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Solco healthcare U.S., LLC)

  FDA approved a supplemental application for benazepril hydrochloride submitted by Solco Healthcare U.S., LLC.

• FDA approval · 2010-04-09
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva Pharmaceuticals' supplemental application for amlodipine besylate (generic). This action confirms the continued availabili…

• FDA approval · 2010-04-07
  FDA Approved: AMLODIPINE BESYLATE 2.5 MG — Original Application (Oxford Pharmaceuticals, LLC)

  FDA approved the Original Application for amlodipine besylate 2.5 mg by Oxford Pharmaceuticals, LLC.

• FDA approval · 2010-04-06
  FDA Approved: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's generic combination of losartan potassium and hydrochlorothiazide for hypertension under ANDA 077157.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2010-03-30
  FDA Approved: EXFORGE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for EXFORGE, a fixed-dose combination of amlodipine besylate and valsartan, submitted by Novarti…

• FDA approval · 2010-03-30
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for carvedilol (generic), authorizing the continued marketing of a generic carvedilol product w…

• FDA approval · 2010-03-30
  FDA Approved: MOEXIPRIL HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's moexipril hydrochloride as an Original Application (ANDA) for a generic version of an ACE inhibitor used to treat hy…

• FDA approval · 2010-03-29
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2010-03-17
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Benazepril hydrochloride and hydrochlorothiazide from Sandoz Inc.

• FDA approval · 2010-03-16
  FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for Cardura XL (doxazosin mesylate) by Viatris Specialty LLC to modify or expand the labeling.

• FDA approval · 2010-03-15
  FDA Approved: MATZIM LA — Original Application (Actavis Pharma, Inc.)

  FDA approved MATZIM LA, a diltiazem hydrochloride extended-release tablet, under Actavis Pharma's original ANDA.

• FDA approval · 2010-03-12
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited.

• FDA approval · 2010-03-11
  FDA Approved: CLONIDINE HYDROCHLORIDE — Supplemental Application (TruPharma, LLC)

  The FDA approved a supplemental application for clonidine hydrochloride (generic) from TruPharma, LLC.

• FDA approval · 2010-03-10
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for metoprolol tartrate.

• FDA approval · 2010-02-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved the original application for hydralazine hydrochloride, a generic antihypertensive. The approval covers a product manufactured …

• FDA approval · 2010-02-19
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (GSMS, Incorporated)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide combination from GSMS, Incorporated. The document provide…

• FDA approval · 2010-02-19
  FDA Approved: BYSTOLIC — Supplemental Application (Allergan, Inc.)

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

• FDA approval · 2010-02-17
  FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application from Prasco Laboratories to market a generic fixed-dose combination of amlodipine besylate and atorv…

• FDA approval · 2010-02-17
  FDA Approved: NORVASC — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for NORVASC (amlodipine besylate) submitted by Viatris Specialty LLC.

• FDA approval · 2010-02-05
  FDA Approved: AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin's amlodipine besylate and benazepril hydrochloride as an original-application generic product for hypertension.

• FDA approval · 2010-02-04
  FDA Approved: BENICAR — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Benicar (olmesartan medoxomil) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2010-02-04
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Hydralazine Hydrochloride submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutic…

• FDA approval · 2010-01-29
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for benazepril hydrochloride from Amneal Pharmaceuticals of New York LLC (generic benazepril hydroch…

• FDA approval · 2010-01-28
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  FDA approved a supplemental application for Quinapril submitted by Cipla USA Inc. The approval confirms continued availability of Quinapril …