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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, Lupin Ltd, Torrent Pharms Ltd, Boehringer Ingelheim, and Par Pharm Inc, and is included in thirty-six NDAs. There are twelve 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

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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Matrix Labs Ltd
amlodipine besylate
TABLET; ORAL078224Feb 27, 2008RXNo<disabled><disabled>
amlodipine besylate; valsartan
TABLET; ORAL021990Jun 20, 2007RXYes6,294,197*PED<disabled><disabled>
amlodipine besylate; atorvastatin calcium
TABLET; ORAL021540Jan 30, 2004RXNo5,686,104*PED<disabled><disabled>
amlodipine besylate; benazepril hydrochloride
CAPSULE; ORAL020364Apr 11, 2006RXNo6,162,802<disabled>YY<disabled>
Boehringer Ingelheim
amlodipine besylate; telmisartan
TABLET; ORAL022401Oct 16, 2009RXYes<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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