FDA.reportPublic FDA data

Application 204441

Type
NDA
Sponsor
OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JYNARQUETOLVAPTANTABLET;ORAL15MGYesNo
002JYNARQUETOLVAPTANTABLET;ORAL30MGYesNo
003JYNARQUETOLVAPTANTABLET;ORAL45MGYesYes
004JYNARQUETOLVAPTANTABLET;ORAL60MGYesNo
005JYNARQUETOLVAPTANTABLET;ORAL90MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-079JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-079JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-079JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-079JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-079JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-080JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-080JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-080JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-080JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-080JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-082JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-083JYNARQUEtolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-087JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-088JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent
59148-089JynarquetolvaptanOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82093SUPPL 2025-05-01
81734SUPPL 2025-03-26
76351ORIG 2023-11-06
75649SUPPL 2023-10-03
65512SUPPL2020-12-07
65360SUPPL2020-11-27
64962SUPPL2020-10-21
61147SUPPL2019-12-04
56664SUPPL2018-12-07
56631SUPPL2018-12-04
55387ORIG2018-09-05
55386ORIG2018-09-05
55088SUPPL2018-08-03
54478ORIG2018-06-08
53813ORIG2018-04-24