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Generic Name: amlodipine besylate; valsartan

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; ORAL10MG; 160MG

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

Litigation for: AMLODIPINE


Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090011Mar 28, 2013RXNo<disabled>
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090144Mar 28, 2013RXNo<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990Jun 20, 2007RXNo6,395,728<disabled>Y
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990Jun 20, 2007RXNo6,294,197*PED<disabled>Y
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