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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208647

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EZALLOR SPRINKLE (ROSUVASTATIN CALCIUM)
EQ 5MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: EZALLOR SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208647
Product Number: 001
Approval Date: Dec 18, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
EZALLOR SPRINKLE (ROSUVASTATIN CALCIUM)
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: EZALLOR SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208647
Product Number: 002
Approval Date: Dec 18, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
EZALLOR SPRINKLE (ROSUVASTATIN CALCIUM)
EQ 20MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: EZALLOR SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208647
Product Number: 003
Approval Date: Dec 18, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
EZALLOR SPRINKLE (ROSUVASTATIN CALCIUM)
EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: EZALLOR SPRINKLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208647
Product Number: 004
Approval Date: Dec 18, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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