Product Details for NDA 204441
JYNARQUE (TOLVAPTAN)
15MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
45MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
90MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
Active Ingredient: TOLVAPTAN
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 001
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
JYNARQUE (TOLVAPTAN)
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 001
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: TOLVAPTAN
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 002
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
JYNARQUE (TOLVAPTAN)
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 002
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
45MG
Marketing Status: Prescription
Active Ingredient: TOLVAPTAN
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204441
Product Number: 003
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
JYNARQUE (TOLVAPTAN)
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204441
Product Number: 003
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: TOLVAPTAN
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 004
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
JYNARQUE (TOLVAPTAN)
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 004
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
90MG
Marketing Status: Prescription
Active Ingredient: TOLVAPTAN
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 005
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: JYNARQUE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204441
Product Number: 005
Approval Date: Apr 23, 2018
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information