Dyslipidemia

• FDA approval · 2026-08-04
  FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)

  Supplemental approval for fenofibrate from Bostal LLC.

• FDA approval · 2025-10-01
  FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Fenofibrate submitted by Lupin Pharmaceuticals, Inc., indicating a regulatory change to this…

• FDA approval · 2025-06-06
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

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

• FDA approval · 2025-03-13
  FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for atorvastatin calcium filed by Novadoz Pharmaceuticals LLC.

• FDA approval · 2024-08-22
  FDA Approved: FENOFIBRATE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for fenofibrate submitted by Aurobindo Pharma Limited, relating to a generic fenofibrate product.

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• FDA approval · 2024-01-16
  FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)

  FDA approved Biocon Pharma's supplemental application for simvastatin (ANDA078034), approving a generic simvastatin product filing.

• FDA approval · 2023-07-20
  FDA Approved: ZETIA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC.

• FDA approval · 2023-07-19
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Fenofibric Acid by Micro Labs Limited.

• FDA approval · 2023-06-21
  FDA Approved: FENOFIBRIC ACID — Supplemental Application (Leading Pharma, LLC)

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

• FDA approval · 2023-02-02
  FDA Approved: NIACIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for NIACIN (niacin) from Sun Pharmaceutical Industries, Inc. under ANDA200484.

• FDA approval · 2022-11-29
  FDA Approved: NIACIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental ANDA for NIACIN (nicotinic acid) from Aurobindo Pharma Limited, authorizing the marketing of a generic NIACIN pr…

• FDA approval · 2022-05-25
  FDA Approved: FENOFIBRATE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals’ supplemental application for fenofibrate, authorizing the marketing of a generic fenofibrate product.

• FDA approval · 2022-04-05
  FDA Approved: FENOFIBRATE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved Alembic Pharmaceuticals' supplemental application for fenofibrate, enabling a generic fenofibrate product.

• FDA approval · 2022-03-03
  FDA Approved: NIACIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for NIACIN (nicotinic acid) from Macleods Pharmaceuticals Limited, establishing a generic version of t…

• FDA approval · 2021-09-20
  FDA Approved: FENOFIBRATE — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for generic fenofibrate by Aurobindo Pharma Limited.

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

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

• FDA approval · 2021-06-03
  FDA Approved: FENOFIBRATE — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for fenofibrate from Rhodes Pharmaceuticals L.P., updating the approved generic product.

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

  FDA approved a supplemental application for fenofibrate by Glenmark Pharmaceuticals Inc., USA under ANDA205566, resulting in updated labelin…

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

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

• FDA approval · 2020-12-10
  FDA Approved: LOPID — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for Lopid (gemfibrozil) submitted by Parke-Davis Div of Pfizer Inc.