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Generated: November 13, 2018

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Details for New Drug Application (NDA): 204441

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NDA 204441 describes JYNARQUE, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the JYNARQUE profile page.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tolvaptan profile page.
Summary for 204441
Tradename:JYNARQUE
Applicant:Otsuka Pharm Co Ltd
Ingredient:tolvaptan
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 204441
Suppliers and Packaging for NDA: 204441
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JYNARQUE tolvaptan TABLET;ORAL 204441 NDA Otsuka America Pharmaceutical, Inc. 59148-082 59148-082-13 1 BOTTLE in 1 CARTON (59148-082-13) > 30 TABLET in 1 BOTTLE
JYNARQUE tolvaptan TABLET;ORAL 204441 NDA Otsuka America Pharmaceutical, Inc. 59148-083 59148-083-13 1 BOTTLE in 1 CARTON (59148-083-13) > 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 23, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 23, 2025
Regulatory Exclusivity Use:INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Regulatory Exclusivity Expiration:Apr 23, 2021
Regulatory Exclusivity Use:USE OF TOLVAPTAN TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Patent:➤ Try a Free TrialPatent Expiration:May 19, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE

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