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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021540

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NDA 021540 describes CADUET, which is a drug marketed by Pharmacia and is included in one NDA. It is available from three suppliers. Additional details are available on the CADUET profile page.

The generic ingredient in CADUET is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Summary for 021540

Tradename:	CADUET
Applicant:	Pharmacia
Ingredient:	amlodipine besylate; atorvastatin calcium
Patents:	0

Pharmacology for NDA: 021540

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors

Suppliers and Packaging for NDA: 021540

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2260	0069-2260-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-2260-30)
CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540	NDA	Pfizer Laboratories Div Pfizer Inc	0069-6180	0069-6180-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-6180-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;EQ 10MG BASE
Approval Date:	Jan 30, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;EQ 20MG BASE
Approval Date:	Jan 30, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;EQ 40MG BASE
Approval Date:	Jan 30, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021540

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-001	Jan 30, 2004	6,126,971*PED	⤷ Get Started Free
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	5,969,156*PED	⤷ Get Started Free
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	6,455,574	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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