Heart Failure

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

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

• 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.

• FDA approval · 2007-11-13
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for carvedilol, indicating an approved labeling change for the drug.

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• FDA approval · 2007-11-13
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for CAPTOPRIL (captopril), approving an additional change to the approved ANDA…

• FDA approval · 2007-11-07
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for torsemide from Chartwell RX, LLC, updating the label for this generic diuretic.

• FDA approval · 2007-10-30
  FDA Approved: DIGOXIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Digoxin under an original ANDA, allowing generic Digoxin from Hikma Pharmaceuticals USA Inc. to be marketed.

• FDA approval · 2007-10-25
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC to market a generic version of the drug.

• FDA approval · 2007-10-23
  FDA Approved: QUINAPRIL — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Quinapril submitted by BluePoint Laboratories. This approval updates the existing Quinapril …

• FDA approval · 2007-10-19
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  The FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC.

• FDA approval · 2007-10-19
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for carvedilol submitted by Aurobindo Pharma Limited for a generic product.

• FDA approval · 2007-10-19
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for carvedilol filed by Dr. Reddy's Laboratories Limited.

• FDA approval · 2007-10-17
  FDA Approved: TORSEMIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original Abbreviated New Drug Application for torsemide from Rising Pharma Holdings, granting regulatory clearance for a ge…

• FDA approval · 2007-10-16
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's supplemental application for a generic carvedilol product (ANDA 078165). This approval expands the availab…

• FDA approval · 2007-10-03
  FDA Approved: TORSEMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Torsemide from Chartwell RX, LLC.

• FDA approval · 2007-09-19
  FDA Approved: HYDROCHLOROTHIAZIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved hydrochlorothiazide from Aurobindo Pharma Limited under an Original Application (ANDA).

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for carvedilol (generic) from Glenmark, enabling generic access to carvedilol for the indicated condit…

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Carvedilol on an original application by Dr. Reddy's Laboratories Limited (generic carvedilol).

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Advagen Pharma Ltd)

  FDA approved the original application for Carvedilol from Advagen Pharma Ltd, a generic version of carvedilol. The drug is indicated for hyp…

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Sandoz Inc)

  The FDA approved a generic version of Carvedilol from Sandoz Inc (ANDA) for multiple cardiovascular indications, including hypertension, hea…

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved an original application for carvedilol generic by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Aurobindo Pharma Limited)

  FDA approves the original ANDA for carvedilol by Aurobindo Pharma Limited, authorizing a generic version of carvedilol. The approval covers …

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved the original application for a generic carvedilol tablet from Unichem Pharmaceuticals (USA), Inc., expanding access to carvedil…

• FDA approval · 2007-09-05
  FDA Approved: CARVEDILOL — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva’s generic carvedilol under an Original Application (ANDA) for a generic version, expanding available generic options f…