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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200153

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LIPTRUZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LIPTRUZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200153
Product Number: 001
Approval Date: May 3, 2013
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
LIPTRUZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LIPTRUZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200153
Product Number: 002
Approval Date: May 3, 2013
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
LIPTRUZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LIPTRUZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200153
Product Number: 003
Approval Date: May 3, 2013
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
LIPTRUZET (ATORVASTATIN CALCIUM; EZETIMIBE)
EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ATORVASTATIN CALCIUM; EZETIMIBE
Proprietary Name: LIPTRUZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200153
Product Number: 004
Approval Date: May 3, 2013
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Discontinued
Patent and Exclusivity Information
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