Last Updated: June 9, 2026

Details for New Drug Application (NDA): 078226

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NDA 078226 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, Puracap Labs Blu, Puracap Pharm, Sciegen Pharms, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Teva Pharms Inc, 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, and Torrent, and is included in seventy-three 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 078226

Tradename:	AMLODIPINE BESYLATE
Applicant:	Zydus Pharms Usa
Ingredient:	amlodipine besylate
Patents:	0

Pharmacology for NDA: 078226

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 078226

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078226	ANDA	Major Pharmaceuticals	0904-6369	0904-6369-61	100 BLISTER PACK in 1 CARTON (0904-6369-61) / 1 TABLET in 1 BLISTER PACK
AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078226	ANDA	Major Pharmaceuticals	0904-6370	0904-6370-61	100 BLISTER PACK in 1 CARTON (0904-6370-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Jul 9, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 9, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 9, 2007	TE:	AB	RLD:	No

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