Details for New Drug Application (NDA): 022314

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NDA 022314 describes EXFORGE HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the EXFORGE HCT profile page.

The generic ingredient in EXFORGE HCT 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 022314

Tradename:	EXFORGE HCT
Applicant:	Novartis
Ingredient:	amlodipine besylate; hydrochlorothiazide; valsartan
Patents:	0

Pharmacology for NDA: 022314

Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Suppliers and Packaging for NDA: 022314

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314	NDA	Novartis Pharmaceuticals Corporation	0078-0559	0078-0559-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0559-15)
EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314	NDA	Novartis Pharmaceuticals Corporation	0078-0560	0078-0560-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0560-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;12.5MG;160MG
Approval Date:	Apr 30, 2009	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;25MG;160MG
Approval Date:	Apr 30, 2009	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;12.5MG;160MG
Approval Date:	Apr 30, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022314

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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