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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078021

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NDA 078021 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, 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-five NDAs. It is available from seventy-five 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. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 078021
Tradename:AMLODIPINE BESYLATE
Applicant:Aurobindo Pharma
Ingredient:amlodipine besylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078021
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 078021
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078021 ANDA Rising Pharmaceuticals, Inc. 64980-390 N 64980-390-09
AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078021 ANDA Rising Pharmaceuticals, Inc. 64980-390 N 64980-390-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 17, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 17, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 17, 2007TE:ABRLD:No

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