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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 077955

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NDA 077955 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, Graviti Pharms, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Mylan, Orbion Pharms, Oxford Pharms, Pharmobedient, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Hetero Labs, Macleods Pharms Ltd, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Torrent, and Lupin Ltd, and is included in seventy-two NDAs. It is available from forty 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. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for 077955

Tradename:	AMLODIPINE BESYLATE
Applicant:	Invagen Pharms
Ingredient:	amlodipine besylate
Patents:	0

Pharmacology for NDA: 077955

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 077955

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	077955	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-989	43353-989-30	30 TABLET in 1 BOTTLE (43353-989-30)
AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	077955	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-989	43353-989-45	45 TABLET in 1 BOTTLE (43353-989-45)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Aug 28, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Aug 28, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Aug 28, 2007	TE:	AB	RLD:	No

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