Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021540

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CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 2.5MG BASE;EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 009
Approval Date: Jul 29, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 2.5MG BASE;EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 010
Approval Date: Jul 29, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 2.5MG BASE;EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE;EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 011
Approval Date: Jul 29, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 5MG BASE;EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 001
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 5MG BASE;EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 002
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 5MG BASE;EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 003
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 5MG BASE;EQ 80MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 004
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 10MG BASE;EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 005
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 10MG BASE;EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 006
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 10MG BASE;EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021540
Product Number: 007
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

CADUET (AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM)
EQ 10MG BASE;EQ 80MG BASE
Marketing Status: Prescription

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: CADUET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021540
Product Number: 008
Approval Date: Jan 30, 2004
Applicant Holder Full Name: PHARMACIA AND UPJOHN CO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information