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Details for Generic Name: atorvastatin calcium

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Atorvastatin calcium is the generic ingredient in three branded drugs marketed by Apotex Inc, Dr Reddys Labs Ltd, Kudco Ireland, Mylan Pharms Inc, Ranbaxy Labs Ltd, Sandoz Inc, Teva Pharms, Pfizer, and Merck Sharp Dohme, and is included in ten NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-seven drug master file entries for atorvastatin calcium. Seventeen suppliers are listed for this compound.

Summary for Generic Name: atorvastatin calcium

Drug Master File Entries: see list57
Suppliers: see list17
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: atorvastatin calcium

Clinical Trials for: atorvastatin calcium

CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
Status: Recruiting Condition: Healthy

Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Status: Completed Condition: Hypertriglyceridemia

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy Labs Ltd
atorvastatin calcium
TABLET;ORAL076477Nov 30, 2011RXNo<disabled><disabled>
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXNoRE42461*PED<disabled><disabled>
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXYesRE42461*PED<disabled><disabled>
Merck Sharp Dohme
atorvastatin calcium; ezetimibe
TABLET;ORAL200153May 3, 2013RXNo5,846,966*PED<disabled>Y<disabled>
atorvastatin calcium
TABLET;ORAL020702Dec 17, 1996RXNo5,686,104*PED<disabled>Y<disabled>
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