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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021990

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NDA 021990 describes EXFORGE, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the EXFORGE profile page.

The generic ingredient in EXFORGE 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 021990

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

Pharmacology for NDA: 021990

Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 021990

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990	NDA	Novartis Pharmaceuticals Corporation	0078-0488	0078-0488-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15)
EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990	NDA	Novartis Pharmaceuticals Corporation	0078-0489	0078-0489-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15)

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;160MG
Approval Date:	Jun 20, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;160MG
Approval Date:	Jun 20, 2007	TE:	AB	RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;320MG
Approval Date:	Jun 20, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021990

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	5,399,578*PED	⤷ Get Started Free
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	6,294,197*PED	⤷ Get Started Free
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	6,395,728	⤷ Get Started Free
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	5,399,578*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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