Heart Failure

• FDA approval · 2013-06-12
  FDA Approved: ALDACTONE — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for Aldactone (spironolactone) from Pfizer. The approval updates the drug’s labeling.

• FDA approval · 2013-05-16
  FDA Approved: LANOXIN — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for LANOXIN (digoxin) submitted by Covis Pharma US, Inc.

• FDA approval · 2013-05-14
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for carvedilol from Aurobindo Pharma Limited, granting approval of an additional generic carvedi…

• FDA approval · 2013-05-07
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for carvedilol from Dr. Reddy's Laboratories Limited (ANDA) to modify or update the approved product…

• FDA approval · 2013-05-07
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for carvedilol submitted by Sandoz Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2013-05-03
  FDA Approved: CANDESARTAN CILEXETIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for candesartan cilexetil (generic) by Mylan Pharmaceuticals Inc., authorizing the marketing of a gene…

• FDA approval · 2013-04-29
  FDA Approved: QUINAPRIL — Original Application (Aurobindo Pharma Limited)

  FDA approves the original generic application for quinapril hydrochloride (quinapril HCl) from Aurobindo Pharma Limited.

• FDA approval · 2013-04-26
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Hydralazine hydrochloride from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2013-04-17
  FDA Approved: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved Baxter Healthcare's supplemental application for dobutamine hydrochloride in dextrose. The approval covers the dobutamine hydro…

• FDA approval · 2013-03-27
  FDA Approved: BIDIL — Supplemental Application (Azurity Pharmaceuticals, Inc.)

  FDA approved a supplemental NDA for BIDIL (hydralazine hydrochloride and isosorbide dinitrate) from Azurity Pharmaceuticals, Inc. The action…

• FDA approval · 2013-02-21
  FDA Approved: ATACAND — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ATACAND (candesartan cilexetil) filed by ANI Pharmaceuticals, Inc., updating its labeling.

• FDA approval · 2013-02-20
  FDA Approved: LISINOPRIL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for lisinopril (Actavis Pharma, Inc.).

• FDA approval · 2013-02-05
  FDA Approved: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Spironolactone and Hydrochlorothiazide from Mylan Pharmaceuticals Inc. (ANDA 086513).

• FDA approval · 2013-01-28
  FDA Approved: HYDRALAZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for hydralazine hydrochloride from Teva Pharmaceuticals USA, Inc. (generic) under an Abbreviated New…

• FDA approval · 2013-01-07
  FDA Approved: TORSEMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' torsemide supplemental application (ANDA 079234), resulting in an approved updated torsemide product un…

• FDA approval · 2012-12-19
  FDA Approved: LOSARTAN POTASSIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)

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

• FDA approval · 2012-12-19
  FDA Approved: LOSARTAN POTASSIUM 25 MG — Supplemental Application (Strides Pharma Science Limited)

  FDA approved the supplemental application for Losartan Potassium 25 mg by Strides Pharma Science Limited, authorizing the generic product fo…

• FDA approval · 2012-12-17
  FDA Approved: QUINAPRIL — Supplemental Application (Cipla USA Inc.)

  The FDA approved a supplemental application for Quinapril from Cipla USA Inc., marking an additional regulatory action for this ACE inhibito…

• FDA approval · 2012-12-12
  FDA Approved: TORSEMIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for torsemide from Teva Pharmaceuticals USA, Inc., updating or expanding the product's labeling.

• FDA approval · 2012-11-30
  FDA Approved: FUROSEMIDE — Supplemental Application (Ipca Laboratories Limited)

  The FDA approved a supplemental application for furosemide from Ipca Laboratories Limited, indicating approval of their generic furosemide p…

• FDA approval · 2012-11-08
  FDA Approved: BENAZEPRIL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• FDA approval · 2012-09-26
  FDA Approved: TORSEMIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals, Inc.'s supplemental application for torsemide, authorizing a modification to the torsemide product unde…

• FDA approval · 2012-09-26
  FDA Approved: TORSEMIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for torsemide from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-09-18
  FDA Approved: TORSEMIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for torsemide from Rising Pharma Holdings, Inc., indicating regulatory approval of changes to the to…

• FDA approval · 2012-09-13
  FDA Approved: VASERETIC — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for VASERETIC (enalapril maleate and hydrochlorothiazide) submitted by Bausch Health US, LLC.