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Generic Name: amlodipine besylate; valsartan

Summary for Generic Name: amlodipine besylate; valsartan

Tradenames:2
Patents:3
Applicants:2
NDAs:3
Drug Master File Entries: see list41
Suppliers: see list2

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; 160MG

Clinical Trials for: amlodipine besylate; valsartan

Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
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 and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Status: Completed Condition: Hypertension

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/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
Status: Completed Condition: Essential Hypertension

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With 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. Product Substance Delist_Flag Patent Expiration Patented / Exclusive Use
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXNo6,395,728Y<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXNo5,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXNo6,294,197*PEDY<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXYes6,395,728Y<disabled>
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