AMLODIPINE BESYLATE

Post-LOE

amlodipine besylate

Teva

ANDAORALTABLET2 Generics Approved

Approved

Jun 2007

Lifecycle

Post-LOE

Competitive Pressure

60/100

Clinical Trials

Data completeness

3/8 — Basic

Drug data last refreshed 23h ago

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Mechanism of Action

Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (13)

NCT03657550Phase 1Completed

Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects

Started May 2018

36 enrolled

Hypertension

NCT02940548Phase 4Terminated

Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness

Started Dec 2016

99 enrolled

Hypertension

NCT02295046Phase 1Completed

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition

Started Oct 2011

80 enrolled

Healthy

NCT02292069Phase 1Completed

Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition

Started Sep 2011

90 enrolled

Healthy

NCT01138826Phase 1Completed

Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

Started May 2010

18 enrolled

Healthy Volunteers

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.