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Details for New Drug Application (NDA): 021540

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NDA 021540 describes CADUET, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the CADUET profile page.

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

Summary for NDA: 021540

Tradename:
CADUET
Applicant:
Pfizer
Ingredient:
amlodipine besylate; atorvastatin calcium
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 021540

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 0069-2150 0069-2150-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-2150-30)
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL 021540 NDA Pfizer Laboratories Div Pfizer Inc 0069-2160 0069-2160-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-2160-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 10MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:No
Patent:5,969,156*PEDPatent Expiration:Jan 8, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,455,574Patent Expiration:Aug 11, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 20MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:No
Patent:5,969,156*PEDPatent Expiration:Jan 8, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021540

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-006Jan 30, 20044,879,303*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-004Jan 30, 20046,126,971*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-006Jan 30, 20044,681,893*PED<disabled>
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