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Generic Name: amlodipine besylate

Summary for Generic Name: amlodipine besylate

Drug Master File Entries: see list45
Suppliers: see list12

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL10MG; 20MG
<disabled><disabled>CAPSULE; ORAL2.5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 10MG

Clinical Trials for: amlodipine besylate

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
Status: Terminated Condition: Hypertension With Metabolic Syndrome

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
Status: Completed Condition: Essential Hypertension

CKD-330 Drug-Drug Interaction Study (Amlodipine)
Status: Completed Condition: Hypertension

Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
See more clinical trials for this drug

Litigation for: AMLODIPINE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Actavis Totowa
amlodipine besylate
TABLET; ORAL078131Sep 4, 2007RXNo<disabled>
amlodipine besylate
TABLET; ORAL078925May 4, 2009RXNo<disabled>
Amneal Pharms Ny
amlodipine besylate
TABLET; ORAL078477Jan 16, 2008RXNo<disabled>
amlodipine besylate
TABLET; ORAL076719May 23, 2007RXNo<disabled>
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