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Details for Generic Name: amlodipine besylate; atorvastatin calcium

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Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Mylan Pharms Inc, and Pfizer, and is included in three NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fourty-six drug master file entries for amlodipine besylate; atorvastatin calcium. Five suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; atorvastatin calcium

Tradenames:2
Patents:4
Applicants:3
NDAs:3
Drug Master File Entries: see list46
Suppliers: see list5

Pharmacology for Ingredient: amlodipine besylate; atorvastatin calcium

Clinical Trials for: amlodipine besylate; atorvastatin calcium

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Status: Completed Condition: Healthy

Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects
Status: Not yet recruiting Condition: Healthy

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk
Status: Completed Condition: Dyslipidemia; Hypertension

Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
Status: Completed Condition: Hypertension; Angina Pectoris; Hypercholesterolemia; Familial Hypercholesterolemia

Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin.
Status: Completed Condition: Essential Hypertension; Hyperlipidemia

Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
Status: Completed Condition: Hypertension; Hyperlipidemia

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540Jan 30, 2004RXNo5,969,156*PED<disabled>Y<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540Jan 30, 2004RXNo6,126,971*PED<disabled><disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540Jan 30, 2004RXYes5,969,156*PED<disabled>Y<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540Jan 30, 2004RXYes6,455,574<disabled><disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540Jul 29, 2004RXNo6,126,971*PED<disabled><disabled>
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