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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 079161

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ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079161
Product Number: 001
Approval Date: Jul 19, 2016
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079161
Product Number: 002
Approval Date: Jul 19, 2016
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079161
Product Number: 003
Approval Date: Jul 19, 2016
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: ROSUVASTATIN CALCIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A079161
Product Number: 004
Approval Date: Jul 19, 2016
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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