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Details for Generic Name: amlodipine besylate

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Amlodipine besylate is the generic ingredient in eight branded drugs marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Matrix Labs Ltd, Mutual Pharma, Mylan, Orchid Hlthcare, Puracap Pharm, Ranbaxy, Roxane, Sandoz, Secan Pharms, Sun Pharm Inds Inc, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher Smith, Vintage, Vivimed Labs, Watson Labs, Wockhardt, Zydus Pharms Usa, Pfizer, Mylan Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Daiichi Sankyo, Symplmed Pharms Llc, Lupin Ltd, Torrent Pharms Ltd, Boehringer Ingelheim, and Par Pharm Inc, and is included in thirty-six NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fourty-six drug master file entries for amlodipine besylate. Twelve suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Drug Master File Entries: see list46
Suppliers: see list12
Formulation / Manufacturing:see details

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

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

Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Status: Recruiting Condition: Chronic Hypertension in Pregnancy

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

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

Courtesy of
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; valsartan
TABLET; ORAL021990-005Jun 20, 2007RXYes6,294,197*PED<disabled><disabled>
amlodipine besylate
TABLET; ORAL077262-002Jul 9, 2007RXNo<disabled><disabled>
amlodipine besylate; atorvastatin calcium
TABLET; ORAL021540-004Jan 30, 2004RXNo6,126,971*PED<disabled><disabled>
amlodipine besylate; benazepril hydrochloride
CAPSULE; ORAL020364-007Apr 11, 2006RXNo<disabled><disabled>
amlodipine besylate
TABLET; ORAL077974-002Jul 9, 2007RXNo<disabled><disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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