Hypertension

• FDA approval · 2009-04-08
  FDA Approved: AMLODIPINE BESYLATE — Original Application (Epic Pharma, LLC)

  The FDA approved the original application for amlodipine besylate from Epic Pharma, LLC, enabling its generic version of the calcium channel…

• FDA approval · 2009-04-06
  FDA Approved: PRAZOSIN HYDROCHLORIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for prazosin hydrochloride submitted by Prasco Laboratories.

• FDA approval · 2009-03-12
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Teva Pharmaceuticals' amlodipine besylate (generic) product, signaling regulatory approval for t…

• FDA approval · 2009-03-12
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC, resulting in updated labeling for the product.

• FDA approval · 2009-02-26
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for metoprolol tartrate from Aurobindo Pharma Limited, confirming regulatory clearance for the gener…

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• FDA approval · 2009-02-25
  FDA Approved: SPIRONOLACTONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2009-02-20
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  The FDA approved a supplemental application for furosemide from Solco Healthcare LLC, adding a new manufacturing source for the product.

• FDA approval · 2009-02-19
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Atenolol filed by Zydus Lifesciences Limited, resulting in approval of a generic Atenolol produc…

• FDA approval · 2009-02-06
  FDA Approved: FUROSEMIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for furosemide submitted by Chartwell RX, LLC.

• FDA approval · 2009-01-30
  FDA Approved: AMILORIDE HYDROCHLORIDE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approves Sigmapharm Laboratories, LLC's amiloride hydrochloride as an original generic application (ANDA) product space.

• FDA approval · 2009-01-22
  FDA Approved: LOTENSIN — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for Lotensin (benazepril hydrochloride) from Validus Pharmaceuticals LLC. The action is a supple…

• FDA approval · 2009-01-22
  FDA Approved: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Benazepril hydrochloride and hydrochlorothiazide (Padagis US LLC), resulting in updated labeling…

• FDA approval · 2009-01-14
  FDA Approved: ATENOLOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for Atenolol by Zydus Lifesciences Limited under an ANDA; this action updates the approved Atenolol …

• FDA approval · 2008-12-31
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental abbreviated new drug application for enalapril maleate from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals…

• FDA approval · 2008-12-23
  FDA Approved: ENALAPRILAT — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s original application for Enalaprilat (ENALAPRILAT), a generic ACE inhibitor, expanding ava…

• FDA approval · 2008-12-22
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol submitted by Teva Pharmaceuticals USA, Inc. (carvedilol).

• FDA approval · 2008-12-19
  FDA Approved: COREG CR — Original Application (Waylis Therapeutics LLC)

  The FDA approves COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC under an Original Application, introducing an extended-release…

• FDA approval · 2008-12-19
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approves Waylis Therapeutics LLC's supplemental application for COREG CR (carvedilol phosphate). This action updates the product under a…

• FDA approval · 2008-12-17
  FDA Approved: DILTIAZEM HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s original application for diltiazem hydrochloride (generic). This approval makes a generic vers…

• FDA approval · 2008-11-26
  FDA Approved: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for Enalapril maleate and hydrochlorothiazide, a combination antihypertensive generic product from T…

• FDA approval · 2008-11-25
  FDA Approved: LABETALOL HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for labetalol hydrochloride from NorthStar Rx LLC, granting approval for this generic antihypertensi…

• FDA approval · 2008-11-18
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approved a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC, authorizing a generic carvedilol tablet pro…

• FDA approval · 2008-11-04
  FDA Approved: METOPROLOL TARTRATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for metoprolol tartrate by Hospira, Inc., indicating regulatory action on this generic product. The …

• FDA approval · 2008-10-22
  FDA Approved: LASIX — Supplemental Application (Validus Pharmaceuticals LLC)

  The FDA approved a supplemental application for LASIX (furosemide) from Validus Pharmaceuticals LLC.

• FDA approval · 2008-10-21
  FDA Approved: AMLODIPINE BESYLATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for amlodipine besylate from Aurobindo Pharma Limited (ANDA 078021). This action approves change…