Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021366

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CRESTOR (ROSUVASTATIN CALCIUM)
EQ 5MG BASE
Marketing Status: Prescription

Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: CRESTOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021366
Product Number: 002
Approval Date: Aug 12, 2003
Applicant Holder Full Name: IPR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CRESTOR (ROSUVASTATIN CALCIUM)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: CRESTOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021366
Product Number: 003
Approval Date: Aug 12, 2003
Applicant Holder Full Name: IPR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CRESTOR (ROSUVASTATIN CALCIUM)
EQ 20MG BASE
Marketing Status: Prescription

Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: CRESTOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021366
Product Number: 004
Approval Date: Aug 12, 2003
Applicant Holder Full Name: IPR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CRESTOR (ROSUVASTATIN CALCIUM)
EQ 40MG BASE
Marketing Status: Prescription

Active Ingredient: ROSUVASTATIN CALCIUM
Proprietary Name: CRESTOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021366
Product Number: 005
Approval Date: Aug 12, 2003
Applicant Holder Full Name: IPR PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information