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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213072

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ROSZET (EZETIMIBE; ROSUVASTATIN CALCIUM)
10MG;EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: EZETIMIBE; ROSUVASTATIN CALCIUM
Proprietary Name: ROSZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213072
Product Number: 001
Approval Date: Mar 23, 2021
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSZET (EZETIMIBE; ROSUVASTATIN CALCIUM)
10MG;EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: EZETIMIBE; ROSUVASTATIN CALCIUM
Proprietary Name: ROSZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213072
Product Number: 002
Approval Date: Mar 23, 2021
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSZET (EZETIMIBE; ROSUVASTATIN CALCIUM)
10MG;EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: EZETIMIBE; ROSUVASTATIN CALCIUM
Proprietary Name: ROSZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213072
Product Number: 003
Approval Date: Mar 23, 2021
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSZET (EZETIMIBE; ROSUVASTATIN CALCIUM)
10MG;EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: EZETIMIBE; ROSUVASTATIN CALCIUM
Proprietary Name: ROSZET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG;EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213072
Product Number: 004
Approval Date: Mar 23, 2021
Applicant Holder Full Name: ALTHERA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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