Hypertension

• FDA approval · 2008-05-22
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for benazepril hydrochloride tablets from Aurobindo Pharma Limited, a generic version of benazepril hy…

• FDA approval · 2008-05-16
  FDA Approved: CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental NDA for candesartan cilexetil and hydrochlorothiazide.

• FDA approval · 2008-05-09
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide by Chartwell RX, LLC, updating an approved generic product (ANDA).

• FDA approval · 2008-05-07
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for EPLERENONE submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2008-05-01
  FDA Approved: HYDROCHLOROTHIAZIDE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for hydrochlorothiazide submitted by Leading Pharma, LLC. This action updates the drug's labelin…

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• FDA approval · 2008-04-29
  FDA Approved: TENORMIN — Supplemental Application (Almatica Pharma LLC)

  FDA approved a supplemental application for TENORMIN (atenolol) submitted by Almatica Pharma LLC.

• FDA approval · 2008-04-29
  FDA Approved: METOPROLOL TARTRATE — Original Application (Hospira, Inc.)

  FDA approves Hospira's original application for metoprolol tartrate as a generic product.

• FDA approval · 2008-04-23
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved a supplemental application for enalapril maleate (a generic ACE inhibitor) by Heritage Pharmaceuticals (d/b/a Avet Pharmace…

• FDA approval · 2008-04-14
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for amlodipine besylate from Teva Pharmaceuticals, approving a generic version of the drug. This…

• FDA approval · 2008-04-10
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's supplemental application for Torsemide, enabling the requested changes to the product's approval.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC, signifying approval of a gener…

• FDA approval · 2008-02-19
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for amlodipine besylate by Zydus Pharmaceuticals USA Inc. under the ANDA framework. The action relat…

• FDA approval · 2008-02-15
  FDA Approved: TOPROL XL — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental NDA for TOPROL XL (metoprolol succinate) from Melinta Therapeutics, LLC, providing an additional or revised appr…

• FDA approval · 2008-02-15
  FDA Approved: ALISKIREN — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Aliskiren hemifumarate (ALISKIREN) submitted by Prasco Laboratories.

• FDA approval · 2008-02-15
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Quinapril submitted by BluePoint Laboratories.

• FDA approval · 2008-01-31
  FDA Approved: EPLERENONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Eplerenone submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2008-01-31
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a generic version of propranolol hydrochloride for the same indications as the brand product, enabling generic competition for …

• FDA approval · 2008-01-29
  FDA Approved: LISINOPRIL AND HYDROCHLOROTHIAZIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for a fixed-dose lisinopril/hydrochlorothiazide product from Actavis, expanding the availability of …

• FDA approval · 2008-01-28
  FDA Approved: LISINOPRIL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for lisinopril from Aurobindo Pharma Limited.

• FDA approval · 2008-01-08
  FDA Approved: LOPRESSOR — Supplemental Application (Validus Pharmaceuticals LLC)

  FDA approved a supplemental application for Lopressor (metoprolol tartrate) filed by Validus Pharmaceuticals LLC.

• FDA approval · 2008-01-07
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-01-02
  FDA Approved: NISOLDIPINE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2007-12-17
  FDA Approved: BYSTOLIC — Original Application (Allergan, Inc.)

  This FDA original approval documents the approval of BYSTOLIC (nebivolol hydrochloride) by Allergan, Inc. for the treatment of hypertension.

• FDA approval · 2007-12-13
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Bisoprolol fumarate (NorthStar Rx LLC), granting supplemental approval for this generic product.