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Details for 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 five suppliers. There are three 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. Five 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:3

Pharmacology for NDA: 021540

Suppliers and Packaging for NDA: 021540

Tradename Generic Name Dosage NDA Supplier National Drug Code Package Code Package
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL 021540 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 Pfizer Laboratories Div Pfizer Inc 0069-2160 0069-2160-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-2160-30)
Glossary

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:5,686,104*PEDPatent Expiration:May 11, 2015Product Flag?Substance Flag?Delist Request?Y
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

Expired Orange Book Patents for NDA: 021540

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 20044,572,909*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 2004RE40667*PED<disabled>
Pfizer
CADUET
amlodipine besylate; atorvastatin calcium
TABLET;ORAL021540-005Jan 30, 20046,126,971*PED<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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