Hypertension

• FDA approval · 2007-05-30
  FDA Approved: METOPROLOL TARTRATE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original ANDA for metoprolol tartrate, a generic beta-blocker used to treat cardiovascular…

• FDA approval · 2007-05-25
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for Enalapril Maleate and Hydrochlorothiazide from Dr. Reddy's Laboratories Limited, approving a gen…

• FDA approval · 2007-05-23
  FDA Approved: AMLODIPINE BESYLATE — Original Application (PD-Rx Pharmaceuticals, Inc.)

  FDA approved a new original-application generic amlodipine besylate tablet from PD-Rx Pharmaceuticals, Inc. Indications include hypertension…

• FDA approval · 2007-05-22
  FDA Approved: ACEBUTOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• FDA approval · 2007-05-11
  FDA Approved: CARTIA XT — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for CARTIA XT (diltiazem hydrochloride) from Actavis Pharma, Inc.

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• FDA approval · 2007-05-07
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for labetalol hydrochloride related to this product, signaling an update or expansion of its regulat…

• FDA approval · 2007-05-01
  FDA Approved: TERAZOSIN — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

  FDA approved a supplemental application for Terazosin hydrochloride from Jubilant Cadista Pharmaceuticals, resulting in labeling changes.

• FDA approval · 2007-04-27
  FDA Approved: CARDIZEM LA — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for Cardizem LA (diltiazem hydrochloride extended-release) from Bausch Health US LLC.

• FDA approval · 2007-04-19
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for verapamil hydrochloride from Actavis Pharma, Inc., granting approval of a supplemental indicatio…

• FDA approval · 2007-04-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Verapamil Hydrochloride from Actavis Pharma, Inc., confirming regulatory approval of an upda…

• FDA approval · 2007-04-12
  FDA Approved: VERAPAMIL HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Verapamil Hydrochloride from Actavis Pharma, Inc., updating the approval status for this generic…

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for furosemide (a generic diuretic) under the ANDA.

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide by Hikma Pharmaceuticals USA Inc., approving regulatory action on an existing generic…

• FDA approval · 2007-03-28
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., resulting in changes to the product labeling…

• FDA approval · 2007-03-16
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Leading Pharma, LLC)

  FDA approved hydrochlorothiazide under Leading Pharma, LLC's original application (ANDA) for use as a diuretic to treat hypertension and ede…

• FDA approval · 2007-03-09
  FDA Approved: CLONIDINE HYDROCHLORIDE — Original Application (Solco Healthcare LLC)

  FDA approved Solco Healthcare LLC's clonidine hydrochloride under an Original Abbreviated New Drug Application (ANDA).

• FDA approval · 2007-03-05
  FDA Approved: ALISKIREN — Original Application (Prasco Laboratories)

  FDA approved Prasco Laboratories' original application for aliskiren hemifumarate, a direct renin inhibitor, for the treatment of hypertensi…

• FDA approval · 2007-03-01
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Atenolol from Zydus Lifesciences Limited under an ANDA. The action approves changes to the g…

• FDA approval · 2007-02-27
  FDA Approved: MICARDIS HCT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for MICARDIS HCT (telmisartan and hydrochlorothiazide) from Boehringer Ingelheim Pharmaceuticals, In…

• FDA approval · 2007-02-27
  FDA Approved: MICARDIS — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for MICARDIS (telmisartan) submitted by Boehringer Ingelheim Pharmaceuticals, Inc.

• FDA approval · 2007-02-27
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved a generic hydrochlorothiazide under an original ANDA from Actavis Pharma, Inc.

• FDA approval · 2007-02-23
  FDA Approved: LOTREL — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2007-02-13
  FDA Approved: LISINOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA supplemental approval for Camber Pharmaceuticals' lisinopril generic under ANDA075903. Lisinopril is used to treat hypertension, heart f…

• FDA approval · 2007-02-06
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for the lisinopril and hydrochlorothiazide fixed-dose combination from Aurobindo Pharma Limited.

• FDA approval · 2007-02-06
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for lisinopril from Aurobindo Pharma Limited, authorizing a generic lisinopril product under an ANDA…