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Details for Generic Name: amlodipine besylate; valsartan

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Summary for Generic Name: amlodipine besylate; valsartan

Tradenames:2
Patents:2
Applicants:2
NDAs:3
Drug Master File Entries: see list45
Suppliers: see list3

Pharmacology for Ingredient: amlodipine besylate; valsartan

Tentative approvals for AMLODIPINE BESYLATE; VALSARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORALEQ 5MG BASE;320MG
<disabled><disabled>TABLET; ORALEQ 10MG BASE;320MG
<disabled><disabled>TABLET; ORAL5MG; 320MG

Clinical Trials for: amlodipine besylate; valsartan

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

Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Status: Completed Condition: Hypertension

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Status: Completed Condition: Essential Hypertension

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Status: Completed Condition: Essential Hypertension

To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Status: Completed Condition: Hypertension; High Blood Pressure

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Status: Completed Condition: Hypertension

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
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990Jun 20, 2007RXYes6,395,728<disabled>Y<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990Jun 20, 2007RXYes6,294,197*PED<disabled>Y<disabled>
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090144Mar 28, 2013RXNo<disabled><disabled>
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090011Mar 28, 2013RXNo<disabled><disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990Jun 20, 2007RXNo6,395,728<disabled>Y<disabled>
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