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Last Updated: January 18, 2020

DrugPatentWatch Database Preview

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. 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. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.
Summary for 021540
Tradename:CADUET
Applicant:Pfizer
Ingredient:amlodipine besylate; atorvastatin calcium
Patents:0
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)
Paragraph IV (Patent) Challenges for 021540
Tradename Dosage Ingredient NDA Submissiondate
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-09-17
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2009-04-07
CADUET TABLET;ORAL amlodipine besylate; atorvastatin calcium 021540 2006-12-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 10MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 20MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE;EQ 40MG BASE
Approval Date:Jan 30, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021540

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