Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-11-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, bringing a rosuvasta…
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FDA approval · 2023-10-30FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Inc)
FDA approved a supplemental application for atorvastatin calcium by Dr. Reddy's Laboratories Inc, confirming approval of the generic formula…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Ohm Laboratories Inc.)
FDA supplemental approval of a generic ezetimibe product by Ohm Laboratories Inc.
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for EZETIMIBE filed by Quallent Pharmaceuticals Health LLC, approving a change to the marketed EZETI…
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for EZETIMIBE from Aurobindo Pharma Limited.
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FDA approval · 2023-10-17FDA Approved: EZETIMIBE — Supplemental Application (ScieGen Pharmaceuticals Inc)
The FDA approved a supplemental application for ezetimibe by ScieGen Pharmaceuticals Inc.
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FDA approval · 2023-10-16FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)
FDA approved the original application for atorvastatin calcium from Cadila Pharmaceuticals Limited. This generic statin is used to treat hyp…
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FDA approval · 2023-09-20FDA Approved: NEXLIZET — Supplemental Application (Esperion Therapeutics, Inc.)
FDA approved a supplemental application for Nexlizet (bempedoic acid and ezetimibe) submitted by Esperion Therapeutics, Inc.
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FDA approval · 2023-08-22FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS)
FDA approved a supplemental application for rosuvastatin calcium from Puracap Laboratories LLC dba Blu Pharmaceuticals, authorizing a generi…
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FDA approval · 2023-08-09FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a Supplemental Application for ZOCOR (simvastatin) submitted by Organon LLC.
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FDA approval · 2023-07-31FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC.
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FDA approval · 2023-07-26FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Cranbury Pharmaceuticals, LLC)
The FDA approved a supplemental application for Colesevelam hydrochloride (ANDA 209946) submitted by Cranbury Pharmaceuticals, LLC.
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FDA approval · 2023-07-20FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Biocon Pharma Inc.)
FDA issued a supplemental approval for atorvastatin calcium from Biocon Pharma Inc. under an ANDA.
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FDA approval · 2023-07-14FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for rosuvastatin calcium (rosuvastatin) from Ascend Laboratories, LLC.
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FDA approval · 2023-07-13FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for ROSUVASTATIN CALCIUM from Torrent Pharmaceuticals Limited, confirming regulatory approval for th…
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FDA approval · 2023-07-13FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental ANDA for rosuvastatin calcium, a generic rosuvastatin salt product.
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FDA approval · 2023-06-30FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for Colesevelam hydrochloride by Dr. Reddy's Laboratories, approving a generic version of the choles…
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FDA approval · 2023-04-25FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2023-03-10FDA Approved: COLESTIPOL HYDROCHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' original-application approval for Colestipol hydrochloride, a generic cholesterol-lowering medicine used t…
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FDA approval · 2022-11-23FDA Approved: ATORVASTATIN CALCIUM — Original Application (Biocon Pharma Inc.)
FDA approval of Biocon Pharma Inc.'s atorvastatin calcium as an original generic application (ANDA) aligned to the reference product labelin…
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FDA approval · 2022-11-03FDA Approved: ATORVASTATIN CALCIUM — Original Application (Lepu Pharmaceutical Technology Co., Ltd.)
FDA approves the original application for atorvastatin calcium (generic) from Lepu Pharmaceutical Technology Co., Ltd. The approval adds a g…
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FDA approval · 2022-11-02FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)
FDA approved a supplemental application for Colesevelam hydrochloride (generic) from Glenmark Pharmaceuticals Inc., USA.
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FDA approval · 2022-10-13FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental ANDA for pravastatin sodium, enabling a generic version of pravastatin.
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FDA approval · 2022-09-28FDA Approved: COLESEVELAM HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc.,USA)
FDA approved a supplemental application for Colesevelam hydrochloride (generic Colesevelam) from Glenmark Pharmaceuticals, authorizing its c…
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FDA approval · 2022-08-29FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin from NorthStar Rx LLC under the ANDA framework, supporting continued regulatory stat…