Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-05-21FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a Supplemental Application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP, updating the drug's labe…
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FDA approval · 2020-04-07FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Glenmark Pharmaceutials Inc., USA)
FDA approved Glenmark's supplemental application for rosuvastatin calcium, authorizing a generic rosuvastatin calcium product and expanding …
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Westminster Pharmaceuticals, LLC)
FDA approves Westminster Pharmaceuticals' supplemental application for rosuvastatin calcium, confirming this rosuvastatin salt as an approve…
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FDA approval · 2020-03-09FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Rosuvastatin Calcium from Rising Pharma Holdings, Inc., enabling this rosuvastatin calcium g…
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FDA approval · 2020-02-21FDA Approved: NEXLETOL — Original Application (Esperion Therapeutics, Inc.)
FDA approved Nexletol (bempedoic acid) as an original application for adults with heterozygous familial hypercholesterolemia or established …
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FDA approval · 2020-02-21FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for Rosuvastatin Calcium from Quallent Pharmaceuticals Health LLC, establishing a generic rosuvastat…
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FDA approval · 2020-01-29FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Ascend Laboratories LLC.
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FDA approval · 2020-01-17FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's fenofibrate generic under an original ANDA (ANDA213252).
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FDA approval · 2019-11-04FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd.)
FDA approves rosuvastatin calcium as a generic drug (Original Application) by Zhejiang Yongtai Pharmaceutical Co., Ltd.
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FDA approval · 2019-10-22FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited under an ANDA to enable continued mar…
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FDA approval · 2019-10-22FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, allowing the generic product to be m…
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FDA approval · 2019-10-21FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s Supplemental Application for atorvastatin calcium, making a generic atorvastatin calcium product an approv…
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FDA approval · 2019-10-16FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for atorvastatin calcium, a generic statin used to treat high cholesterol, unde…
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FDA approval · 2019-09-13FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Bionpharma Inc.)
FDA approved a generic version of colesevelam hydrochloride (Colesevelam HCl) by Bionpharma Inc. under an original ANDA, for lipid-lowering …
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FDA approval · 2019-08-20FDA Approved: CHOLESTYRAMINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved a supplemental application for Cholestyramine submitted by Zydus Pharmaceuticals (USA) Inc. under ANDA202901.
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FDA approval · 2019-08-07FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Simvastatin by NorthStar Rx LLC.
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FDA approval · 2019-06-27FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approves Glenmark's ezetimibe and simvastatin as an original ANDA application, enabling generic availability.
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FDA approval · 2019-05-07FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Shandong New Time Pharmaceutical Co., Ltd.)
FDA approved the original application for rosuvastatin calcium (generic rosuvastatin) from Shandong New Time Pharmaceutical Co., Ltd., expan…
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FDA approval · 2019-04-24FDA Approved: ROSUVASTATIN — Original Application (ScieGen Pharmaceuticals, Inc.)
FDA approved the original ANDA for a generic rosuvastatin product, manufactured by ScieGen Pharmaceuticals, Inc.
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FDA approval · 2019-04-09FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Umedica Laboratories USA Inc.)
FDA approved a generic rosuvastatin calcium product from Umedica Laboratories USA Inc. under an Original Application (ANDA).
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FDA approval · 2019-04-03FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Cranbury Pharmaceuticals, LLC)
FDA approved Cranbury Pharmaceuticals, LLC's supplemental application for Rosuvastatin Calcium, authorizing a generic rosuvastatin calcium p…
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FDA approval · 2019-04-02FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) submitted by Organon LLC.
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FDA approval · 2019-03-22FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approves a supplemental application for the ezetimibe and simvastatin combination by Amneal, indicating a modification to an already-app…
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FDA approval · 2019-02-08FDA Approved: ATORVASTATIN CALCIUM — Original Application (Novadoz Pharmaceuticals LLC)
FDA approves the first original application for atorvastatin calcium as a generic product from Novadoz Pharmaceuticals LLC.