Left Ventricular Dysfunction Following Myocardial Infarction

• FDA approval · 2024-04-16
  FDA Approved: CARVEDILOL PHOSPHATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for carvedilol phosphate from Sun Pharmaceutical, confirming approval of this generic salt formulati…

• FDA approval · 2022-03-30
  FDA Approved: ENALAPRIL MALEATE ORAL SOLUTION — Original Application (Ascend Laboratories, LLC)

  The FDA approved Ascend Laboratories' enalapril maleate oral solution as an original generic application for enalapril; the drug is used to …

• FDA approval · 2020-03-11
  FDA Approved: CARVEDILOL — Supplemental Application (Advagen Pharma Ltd)

  FDA approved a supplemental application for carvedilol (Advagen Pharma Ltd) under an ANDA, authorizing a supplemental approval for this gene…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for CAPTOPRIL by Camber Pharmaceuticals, granting approval of an additional generic captopril produc…

• FDA approval · 2020-03-03
  FDA Approved: CAPTOPRIL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for CAPTOPRIL (captopril) from Hikma Pharmaceuticals USA Inc. under an ANDA. The action concerns…

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• FDA approval · 2020-03-03
  FDA Approved: CARVEDILOL — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a supplemental application for carvedilol from Quallent Pharmaceuticals Health LLC, approving an updated generic product.

• FDA approval · 2018-05-07
  FDA Approved: CARVEDILOL PHOSPHATE — Original Application (AvKARE)

  FDA approved AvKARE's Carvedilol Phosphate as a generic original application, granting market approval for this salt form of carvedilol.

• FDA approval · 2016-04-26
  FDA Approved: CARVEDILOL — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for carvedilol (CARVEDILOL).

• FDA approval · 2016-03-21
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved Glenmark Pharmaceuticals' supplemental application for carvedilol, clearing a generic formulation for regulatory sale. This…

• FDA approval · 2016-02-18
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for carvedilol submitted by Teva Pharmaceuticals USA, Inc., authorizing a generic carvedilol product…

• FDA approval · 2014-11-26
  FDA Approved: CARVEDILOL — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's supplemental application for carvedilol, enabling a generic carvedilol product to be marketed.

• FDA approval · 2014-06-26
  FDA Approved: VALSARTAN — Original Application (Ohm Laboratories Inc.)

  FDA approved Ohm Laboratories Inc.'s valsartan under an Original Abbreviated New Drug Application (ANDA), establishing a generic version of …

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

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

• FDA approval · 2010-03-30
  FDA Approved: CARVEDILOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for carvedilol (generic), authorizing the continued marketing of a generic carvedilol product w…

• 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 — 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 · 2008-11-18
  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 · 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 · 2007-10-16
  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 · 2007-09-05
  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 (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 (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…