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Generated: May 29, 2017

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Amlodipine besylate - Generic Drug Details

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What are the generic drug sources for amlodipine besylate and what is the scope of amlodipine besylate freedom to operate?

Amlodipine besylate
is the generic ingredient in seventeen branded drugs marketed by Sovereign Pharms, Wockhardt, Vintage, Vivimed Labs, Mylan Pharms Inc, Apotex, Aurobindo Pharma, Polygen Pharms, Alkem, Synthon Pharms, Zydus Pharms Usa, Puracap Pharm, Sun Pharm Inds Inc, Gedeon Richter Usa, Lupin, Unichem Labs Ltd, Teva, China Resources, Epic Pharma Llc, Accord Hlthcare, Orchid Hlthcare, Invagen Pharms, Sandoz, Upsher Smith, Genpharm, West-ward Pharms Int, Hikma Pharms, Watson Labs, Cipla Ltd, Torrent Pharms, Sun Pharm Inds Ltd, Amneal Pharms Ny, Macleods Pharms Ltd, Sun Pharm Inds, Pfizer, Dr Reddys Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Mylan, Dr Reddys Labs Inc, Watson Labs Inc, Novartis, Lupin Pharms, Teva Pharms, Par Pharm, Par Pharm Inc, Daiichi Sankyo, Torrent Pharms Ltd, Teva Pharms Usa, Lupin Ltd, Ajanta Pharma Ltd, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, and Novel Labs Inc, and is included in eighty-four NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate has four patent family members in four countries.

There are forty-nine drug master file entries for amlodipine besylate. Seventy-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Drug Master File Entries: see list49
Suppliers / Packagers: see list77
Bulk Api Vendors: see list85
Clinical Trials: see list143
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amlodipine besylate at DailyMed

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MG; 20MGCAPSULE; ORAL
► Subscribe► Subscribe5MG; 20MGCAPSULE; ORAL
► Subscribe► Subscribe5MG; 10MGCAPSULE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL202491-002Nov 3, 2016ABRXNoNo► Subscribe► Subscribe
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-003Jan 30, 2004ABRXYesNo5,969,156*PED► SubscribeY► Subscribe
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL079047-001Jul 5, 2011ABRXNoNo► Subscribe► Subscribe
amlodipine besylate
TABLET;ORAL076719-001May 23, 2007ABRXNoNo► Subscribe► Subscribe
Torrent Pharms Ltd
amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil
TABLET;ORAL203580-005Oct 26, 2016ABRXNoNo► Subscribe► Subscribe
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