Mixed Dyslipidemia

• FDA approval · 2018-11-07
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Fenofibric Acid from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2018-08-28
  FDA Approved: FENOFIBRATE — Original Application (Solco Healthcare US, LLC)

  FDA approved the original application for fenofibrate (generic) from Solco Healthcare US, LLC, authorizing its use for certain lipid disorde…

• FDA approval · 2018-08-17
  FDA Approved: FENOFIBRATE — Original Application (Leading Pharma, LLC)

  FDA approved Leading Pharma, LLC's original Abbreviated New Drug Application for fenofibrate, enabling marketing of a generic fenofibrate pr…

• FDA approval · 2018-07-20
  FDA Approved: FENOFIBRATE — Original Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s generic fenofibrate (FENOFIBRATE) under an Original Abbreviated New Drug Application.

• FDA approval · 2018-06-26
  FDA Approved: FENOFIBRATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Fenofibrate's original application from Torrent Pharmaceuticals Limited under ANDA210782, making a generic option available for…

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• FDA approval · 2018-05-21
  FDA Approved: EZETIMIBE — Supplemental Application (Ascend Laboratories, LLC)

  FDA has approved a supplemental application for ezetimibe from Ascend Laboratories, LLC, authorizing continued marketing under the ANDA.

• FDA approval · 2018-05-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved a supplemental application for fenofibrate submitted by Lupin Pharmaceuticals, Inc. The notice indicates an updated approval fo…

• FDA approval · 2018-05-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)

  FDA approved a supplemental application for fenofibrate filed by Cipla USA Inc. under ANDA207378.

• FDA approval · 2018-05-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC, approving a generic fenofibrate product.

• FDA approval · 2018-05-18
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2018-04-30
  FDA Approved: FENOFIBRATE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' generic fenofibrate under an Original Application (ANDA 209504).

• FDA approval · 2018-04-20
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-02-09
  FDA Approved: FENOFIBRATE — Original Application (AvKARE)

  FDA approved AvKARE's generic fenofibrate under an Original Application (ANDA 209951).

• 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.

• FDA approval · 2017-11-22
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved the original application for rosuvastatin calcium (generic rosuvastatin calcium) from Quallent Pharmaceuticals Health LLC. The …

• FDA approval · 2017-09-07
  FDA Approved: FENOFIBRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s original ANDA for fenofibrate (generic fenofibrate).

• FDA approval · 2017-08-25
  FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…

• FDA approval · 2017-08-04
  FDA Approved: LOVASTATIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for Lovastatin (generic statin). The approval pertains to changes under the AND…

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…

• FDA approval · 2017-04-26
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Dr.Reddys Laboratories Inc)

  FDA approved a new generic fixed-dose combination of ezetimibe and simvastatin from Dr. Reddy's Laboratories Inc under an Original Applicati…

• 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 · 2016-11-29
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate, indicating an approved labeling update or new indication under…

• FDA approval · 2016-11-23
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.

• FDA approval · 2016-10-03
  FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)

  FDA approves a supplemental application for Gemfibrozil from NorthStar Rx LLC under an approved ANDA.

• FDA approval · 2016-09-07
  FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved Amneal Pharmaceuticals of New York LLC's fenofibric acid under an original ANDA for treatment of lipid disorders including …