Hyperlipidemia

• FDA approval · 2006-10-23
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Quallent)

  FDA approves the original application (ANDA) for Pravastatin Sodium (generic pravastatin) from Quallent, establishing a generic statin produ…

• FDA approval · 2006-10-23
  FDA Approved: PRAVASTATIN SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

  FDA approves Dr. Reddy's Laboratories Limited pravastatin sodium under an Original Application (ANDA). This marks a new generic product appr…

• FDA approval · 2006-10-03
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC. This document confirms the app…

• FDA approval · 2006-07-27
  FDA Approved: GEMFIBROZIL — Original Application (Exelan Pharmaceuticals, Inc.)

  FDA approved the original application for a generic Gemfibrozil by Exelan Pharmaceuticals, enabling a generic version of Gemfibrozil to be m…

• FDA approval · 2006-07-03
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC, resulting in updated labeling.…

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• FDA approval · 2006-06-23
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Lipitor (atorvastatin calcium) submitted by Viatris Specialty LLC.

• FDA approval · 2006-05-23
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  The FDA has approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC.