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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Farmers Insurance
US Army
Express Scripts
UBS
Boehringer Ingelheim
Deloitte
Daiichi Sankyo

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202553

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NDA 202553 describes AMLODIPINE BESYLATE, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine Lake, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher-smith Labs, Vintage, Vivimed Global, Watson Labs, West-ward Pharms Int, Wockhardt, Yaopharma Co Ltd, Zydus Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Lupin Ltd, and is included in sixty-six NDAs. It is available from seventy-seven suppliers. There is one patent protecting this drug. Additional details are available on the AMLODIPINE BESYLATE profile page.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 202553
Tradename:AMLODIPINE BESYLATE
Applicant:Accord Hlthcare
Ingredient:amlodipine besylate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Apr 29, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 29, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 29, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
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Mallinckrodt
Baxter
Fuji
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