Mixed Dyslipidemia

• FDA approval · 2016-07-19
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved an original Abbreviated New Drug Application for rosuvastatin calcium from Rising Pharma Holdings, Inc.

• FDA approval · 2016-06-23
  FDA Approved: FENOFIBRATE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original generic application for fenofibrate from Mylan Pharmaceuticals Inc., enabling the marketing of a fenofibrate produ…

• FDA approval · 2016-05-19
  FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)

  The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…

• FDA approval · 2016-05-05
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application (ANDA) for Fenofibrate manufactured by Aurobindo Pharma Limited, authorizing its generic fenofibrate p…

• 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.

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• FDA approval · 2015-11-18
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• FDA approval · 2015-04-17
  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, resulting in a change to its ap…

• FDA approval · 2014-11-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate, confirming approval of a generic fenofibrate product.

• FDA approval · 2014-10-31
  FDA Approved: FENOFIBRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries' generic fenofibrate under an Original Application.

• FDA approval · 2014-03-20
  FDA Approved: NIACIN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original abbreviated new drug application for NIACIN, a generic nicotinic acid product.

• FDA approval · 2013-12-04
  FDA Approved: FENOFIBRIC ACID — Original Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' original application for fenofibric acid, a lipid-lowering agent indicated for certain lipid disorde…

• FDA approval · 2013-10-18
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Fenofibrate submitted by Lupin Pharmaceuticals, Inc. This indicates a change or addition to …

• FDA approval · 2013-08-06
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  The FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., authorizing a new generic version of the drug.

• FDA approval · 2013-07-26
  FDA Approved: FENOFIBRATE — Original Application (Apotex Corp.)

  The FDA approves the original (ANDA) application for fenofibrate from Apotex Corp., granting generic approval for the lipid-lowering medicin…

• FDA approval · 2012-11-30
  FDA Approved: LIPITOR — Supplemental Application (Viatris Specialty LLC)

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

• 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 · 2012-09-05
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2012-03-01
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate.

• FDA approval · 2012-03-01
  FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's original application (ANDA090859) for a generic fenofibrate product, authorizing its marketi…

• FDA approval · 2012-02-28
  FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) filed by Sandoz Inc.

• FDA approval · 2011-12-01
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) by Organon LLC, updating its labeling and indications.

• FDA approval · 2011-06-27
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC under the ANDA. The approval confirms changes…

• FDA approval · 2011-03-14
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for fenofibric acid submitted by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2008-12-12
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., authorizing an update to the produ…

• FDA approval · 2008-06-05
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC to update/expand aspects of its labeling.