Left Ventricular Dysfunction After Myocardial Infarction

• FDA approval · 2024-08-23
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for carvedilol (generic), indicating regulatory approval related to t…

• FDA approval · 2024-01-08
  FDA Approved: ENALAPRIL MALEATE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for enalapril maleate from Aurobindo Pharma Limited, a generic version of enalapril for cardiovascular…

• FDA approval · 2023-11-01
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark's supplemental application for carvedilol, allowing continued marketing of the generic product.

• FDA approval · 2021-08-10
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (Bionpharma Inc.)

  FDA approved ENALAPRIL MALEATE ORAL SOLUTION from Bionpharma Inc. under Original Application ANDA212408.

• FDA approval · 2020-03-02
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol from Teva Pharmaceuticals USA, resulting in updated labeling. The approval confirms c…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2018-08-01
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  FDA approved a supplemental application for enalapril maleate from Oceanside Pharmaceuticals, indicating an updated/expanded labeling for th…

• FDA approval · 2017-10-25
  FDA Approved: CARVEDILOL PHOSPHATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved an original-application generic product of carvedilol phosphate from Sun Pharmaceutical Industries.

• FDA label_change · 2017-09-14
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG (carvedilol) submitted by Waylis Therapeutics LLC, typically involving a label change or n…

• FDA label_change · 2017-09-14
  FDA Approved: COREG CR — Supplemental Application (Waylis Therapeutics LLC)

  FDA approved a supplemental application for COREG CR (carvedilol phosphate) from Waylis Therapeutics LLC, detailing changes related to the C…

• FDA approval · 2016-09-15
  FDA Approved: QUINAPRIL — Original Application (Solco Healthcare US, LLC)

  FDA approves the original application for Quinapril, granting approval for a generic version manufactured by Solco Healthcare US, LLC.

• FDA approval · 2016-04-04
  FDA Approved: CARVEDILOL — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for carvedilol from Aurobindo Pharma Limited, enabling continued market supply of this generic produ…

• FDA approval · 2015-07-21
  FDA Approved: TRANDOLAPRIL — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Trandolapril (generic) under the ANDA program. This confirms regulatory cle…

• FDA approval · 2014-12-24
  FDA Approved: ENALAPRIL MALEATE — Supplemental Application (OCEANSIDE PHARMACEUTICALS)

  FDA approved a supplemental application for Enalapril Maleate by Oceanside Pharmaceuticals under NDA 018998. The approval updates the produc…

• FDA approval · 2014-09-25
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  The FDA approved Advagen Pharma Ltd's supplemental application for carvedilol (generic). This is an approval of a supplemental filing for a …

• FDA approval · 2014-09-17
  FDA Approved: CARVEDILOL — Supplemental Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  The FDA approved a supplemental application for carvedilol, submitted by Unichem Pharmaceuticals (USA), Inc. Carvedilol is a beta-blocker us…

• FDA approval · 2011-01-06
  FDA Approved: COREG — Supplemental Application (Waylis Therapeutics LLC)

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

• FDA approval · 2010-10-21
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for carvedilol by Dr. Reddy's Laboratories Limited, enabling a new generic carvedilol product.

• FDA approval · 2009-12-22
  FDA Approved: CARVEDILOL — Original Application (Advagen Pharma Limited)

  FDA approves the original application for a generic carvedilol product by Advagen Pharma Limited.

• 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 · 2008-08-22
  FDA Approved: CARVEDILOL — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for CARVEDILOL from Dr. Reddy's Laboratories Limited, authorizing its generic carvedilol product for…

• 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.

• 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 · 2007-10-19
  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 · 2007-09-05
  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.