NDC 59148-079

Jynarque

Tolvaptan

Jynarque is a Kit in the Human Prescription Drug category. It is labeled and distributed by Otsuka America Pharmaceutical, Inc.. The primary component is .

Product ID59148-079_9cede030-ad33-c63c-e053-2a95a90a57a7
NDC59148-079
Product TypeHuman Prescription Drug
Proprietary NameJynarque
Generic NameTolvaptan
Dosage FormKit
Marketing Start Date2020-01-31
Marketing CategoryNDA /
Application NumberNDA204441
Labeler NameOtsuka America Pharmaceutical, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 59148-079-28

4 BLISTER PACK in 1 CARTON (59148-079-28) > 1 KIT in 1 BLISTER PACK
Marketing Start Date2020-01-31
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Jynarque" or generic name "Tolvaptan"

NDCBrand NameGeneric Name
59148-082JYNARQUEtolvaptan
59148-083JYNARQUEtolvaptan
59148-087Jynarquetolvaptan
59148-088Jynarquetolvaptan
59148-089Jynarquetolvaptan
59148-079Jynarquetolvaptan
59148-080Jynarquetolvaptan
59148-020SAMSCAtolvaptan
59148-021SAMSCAtolvaptan
60505-4704TOLVAPTANtolvaptan
60505-4705TOLVAPTANtolvaptan

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.