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Last Updated: June 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076692


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NDA 076692 describes AMLODIPINE BESYLATE, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Aurobindo Pharma, China Resources, Cipla, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Oxford Pharms, Polygen Pharms, Puracap Pharm, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Upsher Smith Labs, Watson Labs, Wockhardt, Yaopharma Co Ltd, Yiling, Zydus Pharms Usa, Dr Reddys, Zydus Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, Teva Pharms Usa, Torrent, and Lupin Ltd, and is included in sixty-nine NDAs. It is available from fifty-one 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. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 076692
Tradename:AMLODIPINE BESYLATE
Applicant:Yiling
Ingredient:amlodipine besylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076692
Mechanism of ActionCalcium Channel Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 20, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 20, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 20, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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McKinsey
Harvard Business School
Johnson and Johnson

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