Hypertriglyceridemia

• 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 · 2021-05-14
  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 · 2021-03-08
  FDA Approved: GEMFIBROZIL — Supplemental Application (Northstar RxLLC)

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

• FDA approval · 2021-02-10
  FDA Approved: FENOFIBRATE — Original Application (Bostal LLC)

  FDA approved the original application for fenofibrate by Bostal LLC, enabling the marketing of a generic fenofibrate product for lipid disor…

• FDA approval · 2021-02-02
  FDA Approved: FENOFIBRATE — Supplemental Application (Solco Healthcare US, LLC)

  FDA approved a supplemental application for fenofibrate submitted by Solco Healthcare US, LLC.

• FDA approval · 2021-01-13
  FDA Approved: GEMFIBROZIL — Original Application (XLCare Pharmaceuticals, Inc.)

  FDA approved the original ANDA for Gemfibrozil from XLCare Pharmaceuticals, granting approval for a generic version of the lipid-lowering dr…

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)

  The FDA approved a supplemental application for Omega-3-acid ethyl esters from KD Pharma USA, Inc., confirming continued approval of this ge…

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Omega-3-acid ethyl esters submitted by Chartwell RX, LLC under an ANDA.

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTER — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Omega-3-acid ethyl ester (generic product by Bionpharma Inc.), supporting its continued use for …

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (EPIC PHARMA, LLC)

  FDA approved a supplemental application for Omega-3-acid ethyl esters (Epic Pharma, LLC) resulting in approval of a generic product via an A…

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (KD Pharma USA, Inc.)

  FDA approved KD Pharma USA, Inc.'s supplemental application for Omega-3-acid ethyl esters. Omega-3-acid ethyl esters are used to treat hyper…

• FDA approval · 2021-01-06
  FDA Approved: OMEGA-3-ACID ETHYL ESTERS — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's supplemental application for Omega-3-acid ethyl esters.