Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205199

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 001
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 002
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 003
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE;EQ 80MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 004
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 005
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 006
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 007
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Proprietary Name: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;EQ 80MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205199
Product Number: 008
Approval Date: Nov 18, 2019
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information