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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206084

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LYPQOZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 10MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LYPQOZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A206084
Product Number: 001
Approval Date: Apr 26, 2017
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYPQOZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 20MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LYPQOZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A206084
Product Number: 002
Approval Date: Apr 26, 2017
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYPQOZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 40MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LYPQOZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE;10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A206084
Product Number: 003
Approval Date: Apr 26, 2017
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
LYPQOZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 80MG BASE;10MG
Marketing Status: Prescription
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LYPQOZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 80MG BASE;10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A206084
Product Number: 004
Approval Date: Apr 26, 2017
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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