Familial Combined Hyperlipidemia

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's supplemental application for fenofibrate (generic) under ANDA210782. The approval pertains to…

• FDA approval · 2021-05-14
  FDA Approved: FENOFIBRATE — Supplemental Application (Leading Pharma, LLC)

  The FDA approved a supplemental application for fenofibrate submitted by Leading Pharma, LLC.

• FDA approval · 2019-02-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (NDA021695), a generic fenofibrate product.

• FDA approval · 2017-12-19
  FDA Approved: FENOFIBRATE — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' original application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

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• FDA approval · 2016-12-15
  FDA Approved: FENOFIBRATE — Original Application (Cipla USA Inc.)

  This FDA entry records Cipla USA Inc.'s original approval of a generic fenofibrate tablet for lipid disorders.

• FDA approval · 2015-12-23
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for LIPOFEN (fenofibrate) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2012-12-19
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate, updating the product labeling and/or approvals under a sup…

• FDA approval · 2012-10-19
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC’s supplemental application for fenofibrate, authorizing the generic product's approval.

• FDA approval · 2009-07-14
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for Lopid (gemfibrozil) filed by the Parke-Davis division of Pfizer Inc. The action updates the …