Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022363

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LIVALO (PITAVASTATIN CALCIUM)
EQ 1MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: LIVALO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022363
Product Number: 001
Approval Date: Aug 3, 2009
Applicant Holder Full Name: KOWA CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LIVALO (PITAVASTATIN CALCIUM)
EQ 2MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: LIVALO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022363
Product Number: 002
Approval Date: Aug 3, 2009
Applicant Holder Full Name: KOWA CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LIVALO (PITAVASTATIN CALCIUM)
EQ 4MG BASE
Marketing Status: Prescription

Active Ingredient: PITAVASTATIN CALCIUM
Proprietary Name: LIVALO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022363
Product Number: 003
Approval Date: Aug 3, 2009
Applicant Holder Full Name: KOWA CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information