Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-11-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for pravastatin sodium from Aurobindo Pharma Limited (ANDA077793), authorizing continued marketing o…
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FDA approval · 2016-11-17FDA Approved: PRAVASTATIN SODIUM — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's pravastatin sodium product via an Original Application (ANDA207068).
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FDA approval · 2016-11-09FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for fenofibrate filed by Lupin Pharmaceuticals, Inc. under NDA 021695. The approval updates the feno…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals' rosuvastatin calcium through an Original Application for an Abbreviated New Drug Application (ANDA), …
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare's original application for rosuvastatin as a generic product. Rosuvastatin is used to treat hyperlipidemia an…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Torrent Pharmaceuticals Limited)
FDA approved an Original Application for rosuvastatin calcium from Torrent Pharmaceuticals Limited, granting generic approval for the rosuva…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves rosuvastatin (generic) under an Original Application by Camber Pharmaceuticals, adding a generic statin option for lowering cho…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved an original ANDA for rosuvastatin calcium, enabling a generic version of rosuvastatin calcium manufactured by Puracap Laborator…
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FDA approval · 2016-10-31FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Westminster Pharmaceuticals, LLC)
FDA approved the Original Application for rosuvastatin calcium from Westminster Pharmaceuticals, LLC, granting a generic rosuvastatin calciu…
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FDA approval · 2016-10-03FDA Approved: GEMFIBROZIL — Supplemental Application (NorthStar Rx LLC)
FDA approves a supplemental application for Gemfibrozil from NorthStar Rx LLC under an approved ANDA.
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FDA approval · 2016-10-03FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)
This document indicates FDA approval of a supplemental ANDA for Gemfibrozil from Chartwell RX, LLC.
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FDA approval · 2016-09-07FDA Approved: FENOFIBRIC ACID — Original Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved Amneal Pharmaceuticals of New York LLC's fenofibric acid under an original ANDA for treatment of lipid disorders including …
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FDA approval · 2016-07-19FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Glenmark Pharmaceutials Inc., USA)
FDA approves rosuvastatin calcium as an original generic application from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2016-07-19FDA Approved: ROSUVASTAIN CALCIUM — Original Application (Chartwell RX, LLC)
FDA approves ROSUVASTAIN CALCIUM as an original generic (ANDA) application for rosuvastatin calcium. The approval enables marketing of this …
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FDA approval · 2016-07-19FDA 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.
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FDA approval · 2016-07-12FDA Approved: FENOFIBRATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' fenofibrate generic as an Original Application for the treatment of lipid disorders. The approval cover…
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FDA approval · 2016-06-23FDA 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…
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FDA approval · 2016-06-17FDA Approved: GEMFIBROZIL — Original Application (Cadila Pharmaceuticals Limited)
FDA approved Cadila Pharmaceuticals Limited's original ANDA for gemfibrozil, authorizing a generic version of the lipid-lowering drug.
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FDA approval · 2016-05-19FDA 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…
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FDA approval · 2016-05-05FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). This confirms an approved modification to the gene…
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FDA approval · 2016-05-05FDA 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…
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FDA approval · 2016-04-06FDA 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, resulting in an approved modific…
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FDA approval · 2016-02-24FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, authorizing the generic atorvastatin…
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FDA approval · 2016-02-19FDA Approved: GEMFIBROZIL — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for Gemfibrozil filed by Chartwell RX, LLC under an existing ANDA, indicating regulatory approval re…
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FDA approval · 2016-01-27FDA Approved: FLUVASTATIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic fluvastatin sodium as an original ANDA, enabling its use to treat hyperlipidemia and reduce cardiovascular risk.