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Details for Generic Name: amlodipine besylate

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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; ORAL2.5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 20MG

Clinical Trials for: amlodipine besylate

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

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

Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Status: Completed Condition: Healthy

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

Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
Status: Recruiting Condition: Hypertension

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See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
amlodipine besylate
TABLET; ORAL019787Jul 31, 1992RXYes<disabled><disabled>
amlodipine besylate; benazepril hydrochloride
CAPSULE; ORAL020364Mar 3, 1995RXNo6,162,802<disabled><disabled>
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXNo6,395,728<disabled>Y<disabled>
amlodipine besylate; atorvastatin calcium
TABLET; ORAL021540Jul 29, 2004RXNo6,126,971*PED<disabled><disabled>
Amneal Pharms Ny
amlodipine besylate
TABLET; ORAL078477Jan 16, 2008RXNo<disabled><disabled>
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