Product Details for NDA 208379
ZYPITAMAG (PITAVASTATIN MAGNESIUM)
EQ 2MG BASE
Marketing Status: Prescription
EQ 4MG BASE
Marketing Status: Prescription
EQ 1MG BASE
Marketing Status: Discontinued
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: PITAVASTATIN MAGNESIUM
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208379
Product Number: 002
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZYPITAMAG (PITAVASTATIN MAGNESIUM)
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208379
Product Number: 002
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: PITAVASTATIN MAGNESIUM
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208379
Product Number: 003
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZYPITAMAG (PITAVASTATIN MAGNESIUM)
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208379
Product Number: 003
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1MG BASE
Marketing Status: Discontinued
Active Ingredient: PITAVASTATIN MAGNESIUM
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208379
Product Number: 001
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZYPITAMAG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208379
Product Number: 001
Approval Date: Jul 14, 2017
Applicant Holder Full Name: MEDICURE INTERNATIONAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information