Dyslipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-06-12FDA Approved: FENOFIBRATE — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's fenofibrate Original Application (ANDA213864), authorizing a generic fenofibrate product. This marks an appro…
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FDA approval · 2019-12-09FDA Approved: FENOFIBRATE — Supplemental Application (Apotex Corp.)
The FDA approved Apotex Corp.'s supplemental application for fenofibrate (generic) under ANDA 202252.
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for fenofibrate (generic). This action grants an additional approval to the AND…
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FDA approval · 2019-09-23FDA Approved: FENOFIBRATE — Supplemental Application (AvKARE)
The FDA has approved a supplemental application for AvKARE's fenofibrate product, signaling an update to the approved formulation/manufactur…
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FDA approval · 2019-09-19FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for fenofibrate from Cipla USA Inc. The approval indicates an update or addition via a supplemental …
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FDA approval · 2019-09-06FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved the original application for fenofibrate by Dr. Reddy's Laboratories Inc., authorizing the product as a generic.
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FDA approval · 2019-08-15FDA Approved: FENOFIBRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approves a supplemental application for fenofibrate by Mylan Pharmaceuticals, confirming continued access to this generic triglyceride-l…
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FDA approval · 2019-05-15FDA Approved: LIPOFEN — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Lipofen (fenofibrate) filed by ANI Pharmaceuticals, Inc., marking a regulatory action on thi…
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Cipla USA Inc.,)
FDA approved a supplemental application for fenofibrate from Cipla USA Inc., authorizing an updated generic fenofibrate product.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental ANDA for fenofibrate from Glenmark Pharmaceuticals Inc., USA, authorizing a generic fenofibrate product.
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FDA approval · 2019-05-15FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)
FDA approved a supplemental application for fenofibrate from Bostal LLC, indicating approved changes to the product's labeling/status.
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FDA approval · 2019-03-06FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). The approval concerns Biocon's generic simvastatin…
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FDA approval · 2019-03-01FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved a supplemental ANDA for fenofibrate from Amneal Pharmaceuticals NY LLC, authorizing changes to the approved generic product…
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FDA approval · 2019-02-19FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)
The FDA approved a supplemental application for gemfibrozil by NorthStar Rx LLC.
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FDA approval · 2019-02-04FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for Fenofibrate (NDA021695), a generic fenofibrate product.
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FDA approval · 2018-11-20FDA Approved: ATORVASTATIN CALCIUM — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for atorvastatin calcium from Zydus Lifesciences Limited, granting generic approval for lowering chole…
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FDA approval · 2018-09-10FDA Approved: FENOFIBRATE — Original Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s original ANDA for fenofibrate, a generic lipid-lowering medication.
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FDA approval · 2018-08-28FDA Approved: GEMFIBROZIL — Original Application (Zydus Lifesciences Limited)
FDA approved the original ANDA for Gemfibrozil from Zydus Lifesciences Limited, making a generic fibrate available in the United States.
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FDA approval · 2018-05-18FDA Approved: FENOFIBRATE — Supplemental Application (Bostal LLC)
FDA approved a supplemental application for Fenofibrate submitted by Bostal LLC under ANDA 207805. The approval confirms the continued appro…
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FDA approval · 2018-04-20FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for fenofibrate from Amneal Pharmaceuticals NY LLC.
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FDA approval · 2018-03-19FDA Approved: FENOFIBRATE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's fenofibrate generic under an original application (ANDA). This represents the approval of a fen…
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FDA approval · 2018-02-01FDA Approved: NIACIN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original ANDA for NIACIN, a generic niacin product intended to treat dyslipidemia and related lipid …
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FDA approval · 2017-11-21FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal's original application for a generic fixed-dose combination of ezetimibe and simvastatin (EZETIMIBE AND SIMVASTATIN). Th…
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FDA approval · 2017-10-02FDA Approved: GEMFIBROZIL — Supplemental Application (Exelan Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Gemfibrozil submitted by Exelan Pharmaceuticals, Inc.
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FDA approval · 2017-09-11FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for fenofibrate from Lupin Pharmaceuticals, Inc., signaling an approved modification to the existing…