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.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
Matrix Labs Ltd
|TABLET; ORAL||078224||Feb 27, 2008||RX||No||<disabled>||<disabled>|
amlodipine besylate; valsartan
|TABLET; ORAL||021990||Jun 20, 2007||RX||Yes||6,294,197*PED||<disabled>||<disabled>|
amlodipine besylate; atorvastatin calcium
|TABLET; ORAL||021540||Jan 30, 2004||RX||No||5,686,104*PED||<disabled>||<disabled>|
amlodipine besylate; benazepril hydrochloride
|CAPSULE; ORAL||020364||Apr 11, 2006||RX||No||6,162,802||<disabled>||Y||Y||<disabled>|
amlodipine besylate; telmisartan
|TABLET; ORAL||022401||Oct 16, 2009||RX||Yes||<disabled>||<disabled>|
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