Hyperlipidemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2012-11-15FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for ZOCOR (simvastatin) filed by Organon LLC.
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FDA approval · 2012-10-31FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for the fixed-dose combination of amlodipine besylate and atorvastatin calcium, manufactured by …
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FDA approval · 2012-10-31FDA Approved: ZOCOR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for ZOCOR (simvastatin) submitted by Organon LLC.
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FDA approval · 2012-10-31FDA Approved: LIVALO — Supplemental Application (Kowa Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIVALO (pitavastatin calcium) submitted by Kowa Pharmaceuticals America, expanding or updati…
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FDA approval · 2012-10-19FDA Approved: FENOFIBRATE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC’s supplemental application for fenofibrate, authorizing the generic product's approval.
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FDA approval · 2012-10-12FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)
The FDA approves a supplemental application for Lovastatin from Carlsbad Technology, Inc., enabling approval of a generic lovastatin product…
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FDA approval · 2012-09-28FDA Approved: SIMVASTATIN — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Simvastatin from Accord Healthcare, Inc., updating the approval status under the ANDA.
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FDA approval · 2012-09-05FDA Approved: FENOFIBRIC ACID — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for fenofibric acid from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2012-07-26FDA Approved: AMLODIPINE AND ATORVASTATIN — Supplemental Application (Prasco Laboratories)
The FDA granted supplemental approval for a fixed-dose combination product of amlodipine and atorvastatin by Prasco Laboratories. This appro…
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FDA approval · 2012-07-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (CIPLA USA INC.)
FDA approved a supplemental application for Pravastatin Sodium by Cipla USA Inc., marking an approved change to the product's approval.
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FDA approval · 2012-07-20FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental application for pravastatin sodium from Dr. Reddy's Laboratories Limited.
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FDA approval · 2012-07-17FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)
FDA approves Dr. Reddy's Laboratories Limited's generic atorvastatin calcium for lipid-lowering therapy under an original ANDA.
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FDA approval · 2012-07-17FDA Approved: ATORVASTATIN CALCIUM — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories' atorvastatin calcium as an original ANDA, enabling a generic atorvastatin calcium product.
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FDA approval · 2012-07-12FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for pravastatin sodium (Quallent), resulting in an approved change to the generic product.
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FDA approval · 2012-07-09FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc.
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FDA approval · 2012-07-09FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)
FDA approved a supplemental application for WELCHOL (colesevelam hydrochloride) from Cosette Pharmaceuticals. The approval updates labeling …
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FDA approval · 2012-06-12FDA Approved: FLUVASTATIN — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's generic fluvastatin as an original application, enabling marketing of a generic statin product.
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FDA approval · 2012-05-29FDA Approved: ATORVASTATIN CALCIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approves the atorvastatin calcium generic product from Mylan (Original Application) for use in lowering cholesterol.
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FDA approval · 2012-05-29FDA Approved: ATORVASTATIN CALCIUM — Original Application (Quallent)
The FDA approved Quallent's Abbreviated New Drug Application for atorvastatin calcium, establishing a generic atorvastatin calcium product. …
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FDA approval · 2012-05-03FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium from Aurobindo Pharma Limited, confirming continued approval of this generic …
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FDA approval · 2012-04-20FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
The FDA approves a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., resulting in a generic atorvas…
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FDA approval · 2012-04-11FDA Approved: FLUVASTATIN SODIUM — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved a generic version of fluvastatin sodium through an Original Application (ANDA) by Mylan Pharmaceuticals Inc.
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FDA approval · 2012-03-02FDA Approved: SIMVASTATIN — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for simvastatin submitted by NorthStar Rx LLC, completing the changes described in the supplemental …
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FDA approval · 2012-03-01FDA Approved: FENOFIBRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approves Lupin Pharmaceuticals' supplemental application for fenofibrate.
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FDA approval · 2012-03-01FDA Approved: FENOFIBRATE — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories Limited's original application (ANDA090859) for a generic fenofibrate product, authorizing its marketi…