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Last Updated: March 28, 2024

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, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mylan, Orbion Pharms, 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, Zydus Pharms Usa, Apotex, Dr Reddys, Zydus Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Teva Pharms, Watson Labs Inc, Alembic, Hetero Labs, Novel Labs Inc, Teva Pharms Usa, Torrent, and Lupin Ltd, and is included in sixty-nine NDAs. It is available from forty-two suppliers. 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. Three 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
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 Aurobindo Pharma Limited 65862-101 65862-101-05 500 TABLET in 1 BOTTLE (65862-101-05)
AMLODIPINE BESYLATE amlodipine besylate TABLET;ORAL 078021 ANDA Aurobindo Pharma Limited 65862-101 65862-101-30 30 TABLET in 1 BOTTLE (65862-101-30)

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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