Hyperlipidemia

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

  FDA approved a supplemental application for Fenofibrate (FENOFIBRATE) submitted by Bostal LLC under ANDA207805.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

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

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved a supplemental application for fenofibrate from Ajanta Pharma USA Inc., indicating an approved change to the generic produc…

• 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 (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s supplemental application for fenofibrate.

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

  FDA approved a supplemental application for fenofibrate by Chartwell RX, LLC.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for fenofibrate submitted by NorthStar RxLLC.

• FDA approval · 2021-06-03
  FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

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

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (ANDA 204019).

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

  FDA approved a supplemental application for fenofibrate from Alembic Pharmaceuticals Limited under an ANDA.

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for fenofibrate submitted by Lupin Pharmaceuticals, Inc.

• 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 · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  The FDA approved a supplemental application for fenofibrate from Dr. Reddy's Laboratories, indicating an approved change to the product unde…

• FDA approval · 2021-05-17
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for atorvastatin calcium by Accord Healthcare Inc., authorizing the continued commercialization of t…

• FDA approval · 2021-05-14
  FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for fenofibrate (Amneal Pharmaceuticals NY LLC) under an ANDA.

• 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 · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, authorizing the atorvastatin calcium product unde…

• FDA approval · 2021-05-04
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA granted supplemental approval for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA.

• FDA approval · 2021-03-31
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)

  FDA approved a supplemental application for Colesevelam hydrochloride from Glenmark Pharmaceuticals Inc., USA.

• FDA approval · 2021-03-17
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  FDA approved a supplemental application for a generic ezetimibe and simvastatin product from Dr. Reddy's Laboratories, authorizing its marke…

• FDA approval · 2021-03-15
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for pravastatin sodium to allow Aurobindo Pharma Limited to market a generic pravastatin product in …

• FDA approval · 2021-03-09
  FDA Approved: CHOLESTYRAMINE — Original Application (Precision Dose, Inc.)

  FDA approved an original ANDA for cholestyramine from Precision Dose, Inc., providing a generic version of the bile acid sequestrant.

• FDA approval · 2021-03-08
  FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)

  The FDA approved a supplemental application for Gemfibrozil (generic; Northstar RxLLC) under an ANDA.

• FDA approval · 2021-03-05
  FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Accord Healthcare's generic pravastatin sodium, updating its regulatory status as an approved ge…

• FDA approval · 2021-02-23
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for EZETIMIBE AND SIMVASTATIN by Ascend Laboratories, LLC. The approval covers changes under the…