Application 204441

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JYNARQUE	TOLVAPTAN	TABLET;ORAL	15MG	Yes	No
002	JYNARQUE	TOLVAPTAN	TABLET;ORAL	30MG	Yes	No
003	JYNARQUE	TOLVAPTAN	TABLET;ORAL	45MG	Yes	Yes
004	JYNARQUE	TOLVAPTAN	TABLET;ORAL	60MG	Yes	No
005	JYNARQUE	TOLVAPTAN	TABLET;ORAL	90MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-079	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-079	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-079	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-079	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-079	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-080	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-080	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-080	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-080	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-080	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-082	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-083	JYNARQUE	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-087	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-088	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-089	Jynarque	tolvaptan	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82093	SUPPL	2025-05-01
81734	SUPPL	2025-03-26
76351	ORIG	2023-11-06
75649	SUPPL	2023-10-03
65512	SUPPL	2020-12-07
65360	SUPPL	2020-11-27
64962	SUPPL	2020-10-21
61147	SUPPL	2019-12-04
56664	SUPPL	2018-12-07
56631	SUPPL	2018-12-04
55387	ORIG	2018-09-05
55386	ORIG	2018-09-05
55088	SUPPL	2018-08-03
54478	ORIG	2018-06-08
53813	ORIG	2018-04-24