Heart Failure

• FDA approval · 2011-09-22
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA issued a supplemental approval for Torsemide from Rising Pharma Holdings, approving a generic torsemide product.

• FDA approval · 2011-09-21
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc. This approval pertains to a supplemental submissio…

• FDA approval · 2011-08-29
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (TruPharma LLC)

  The FDA approved a supplemental application for bisoprolol fumarate by TruPharma LLC, under an ANDA.

• FDA approval · 2011-08-29
  FDA Approved: BISOPROLOL FUMARATE — Supplemental Application (NorthStar Rx LLC)

  FDA approved NorthStar Rx LLC's supplemental application for bisoprolol fumarate, confirming approval of a generic product. The approval per…

• FDA approval · 2011-08-02
  FDA Approved: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Quinapril Hydrchloride/Hydrochlorothiazide manufactured by Aurobindo Pharma Limited.

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• FDA approval · 2011-07-26
  FDA Approved: CHLOROTHIAZIDE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' original application for CHLOROTHIAZIDE SODIUM, a thiazide diuretic, for the treatment of hypert…

• FDA approval · 2011-07-22
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for CAPTOPRIL from Hikma Pharmaceuticals USA Inc., indicating additional approval for this generic A…

• FDA approval · 2011-07-21
  FDA Approved: PERINDOPRIL ERBUMINE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic version of perindopril erbumine from Aurobindo Pharma Limited.

• FDA approval · 2011-07-06
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, resulting in labeling updates for the d…

• FDA approval · 2011-07-06
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) submitted by Waylis Therapeutics LLC. The action finalizes the r…

• FDA approval · 2011-06-24
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' supplemental NDA for ATACAND (candesartan cilexetil), resulting in an updated product label. This acti…

• FDA approval · 2011-06-08
  FDA Approved: RAMIPRIL — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings' original application for ramipril (generic ramipril), enabling the company to market a ramipril pro…

• FDA approval · 2011-05-19
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for the Spironolactone and Hydrochlorothiazide combination submitted by Prasco Laboratories.

• FDA approval · 2011-04-01
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, Inc., authorizing the marketing of the generic car…

• FDA approval · 2011-03-30
  FDA Approved: FOSINOPRIL SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for fosinopril sodium from Aurobindo Pharma Limited, making it a generic product.

• FDA approval · 2011-03-22
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Losartan Potassium submitted by Quallent Pharmaceuticals Health LLC.

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Solco Healthcare LLC)

  FDA approved a supplemental application for furosemide from Solco Healthcare LLC under an ANDA, authorizing a manufacturing or labeling chan…

• FDA approval · 2011-01-27
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for furosemide from Ipca Laboratories Limited under an ANDA, signaling approval of changes to the ge…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., updating or adding to the product's labeling and…

• FDA approval · 2011-01-26
  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 existing ANDA.

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide filed by Hikma Pharmaceuticals USA Inc., updating the approved generic product un…

• FDA approval · 2011-01-26
  FDA Approved: FUROSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for furosemide from Hikma Pharmaceuticals USA Inc., authorizing a change to the NDA (such as lab…

• FDA approval · 2011-01-25
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2011-01-25
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC. The action represents a label-related c…

• FDA approval · 2011-01-12
  FDA Approved: RAMIPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for RAMIPRIL (ramipril) from Hikma Pharmaceuticals USA Inc., allowing a generic ramipril product to …