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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204441

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JYNARQUE (TOLVAPTAN)
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)
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)
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)
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)
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
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