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Details for Generic Name: amlodipine besylate; valsartan

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Amlodipine besylate; valsartan is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Lupin, Matrix Labs Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Novartis, and is included in nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are forty-six drug master file entries for amlodipine besylate; valsartan. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate; valsartan

Tradenames:2
Patents:2
Applicants:8
NDAs:9
Drug Master File Entries: see list46
Suppliers: see list4
Formulation / Manufacturing:see details

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

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

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
Par Pharm Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090011-004Mar 28, 2013RXNo<disabled><disabled>
Novel Labs Inc
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL202829-001Mar 30, 2015RXNo<disabled><disabled>
Lupin
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090245-004Mar 30, 2015RXNo<disabled><disabled>
Matrix Labs Ltd
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090483-001Mar 30, 2015RXNo<disabled><disabled>
Lupin
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL090245-003Mar 30, 2015RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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