Product Details for NDA 204790
TIVICAY (DOLUTEGRAVIR SODIUM)
EQ 50MG BASE
Marketing Status: Prescription
EQ 10MG BASE
Marketing Status: Discontinued
EQ 25MG BASE
Marketing Status: Discontinued
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: DOLUTEGRAVIR SODIUM
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204790
Product Number: 001
Approval Date: Aug 12, 2013
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Prescription
Patent and Exclusivity Information
TIVICAY (DOLUTEGRAVIR SODIUM)
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204790
Product Number: 001
Approval Date: Aug 12, 2013
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 10MG BASE
Marketing Status: Discontinued
Active Ingredient: DOLUTEGRAVIR SODIUM
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204790
Product Number: 002
Approval Date: Jun 9, 2016
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Discontinued
Patent and Exclusivity Information
TIVICAY (DOLUTEGRAVIR SODIUM)
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204790
Product Number: 002
Approval Date: Jun 9, 2016
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 25MG BASE
Marketing Status: Discontinued
Active Ingredient: DOLUTEGRAVIR SODIUM
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204790
Product Number: 003
Approval Date: Jun 9, 2016
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TIVICAY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204790
Product Number: 003
Approval Date: Jun 9, 2016
Applicant Holder Full Name: VIIV HEALTHCARE CO
Marketing Status: Discontinued
Patent and Exclusivity Information