An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 204441
Company: OTSUKA

Medication Guide

REMS

Products on NDA 204441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
JYNARQUE	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	AB2	Yes	No
JYNARQUE	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	AB2	Yes	No
JYNARQUE	TOLVAPTAN	45MG	TABLET;ORAL	Prescription	AB	Yes	Yes
JYNARQUE	TOLVAPTAN	60MG	TABLET;ORAL	Prescription	AB2	Yes	No
JYNARQUE	TOLVAPTAN	90MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2018	ORIG-1	Approval		PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2025	SUPPL-14	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204441Orig1s014ltr.pdf
12/16/2024	SUPPL-12	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204441Orig1s012lbl.pdf
09/29/2023	SUPPL-10	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204441Orig1s010ltr.pdf
11/25/2020	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s009ltr.pdf
10/19/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204441s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204441Orig1s008ltr.pdf
12/03/2019	SUPPL-7	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204441Orig1s007ltr.pdf
12/01/2018	SUPPL-2	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441s002ltr.pdf
07/30/2018	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204441Orig1s001Ltr.pdf

Labels for NDA 204441

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2024	SUPPL-12	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204441Orig1s012lbl.pdf
10/19/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204441s008lbl.pdf
12/01/2018	SUPPL-2	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441s002lbl.pdf
04/23/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204441lbl.pdf

Therapeutic Equivalents for NDA 204441

JYNARQUE

TABLET;ORAL; 15MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JYNARQUE	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	Yes	AB2	204441	OTSUKA
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB2	218381	APOTEX
TOLVAPTAN	TOLVAPTAN	15MG	TABLET;ORAL	Prescription	No	AB2	216063	LUPIN LTD

TABLET;ORAL; 30MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JYNARQUE	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	Yes	AB2	204441	OTSUKA
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB2	218381	APOTEX
TOLVAPTAN	TOLVAPTAN	30MG	TABLET;ORAL	Prescription	No	AB2	216063	LUPIN LTD

TABLET;ORAL; 45MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JYNARQUE	TOLVAPTAN	45MG	TABLET;ORAL	Prescription	Yes	AB	204441	OTSUKA
TOLVAPTAN	TOLVAPTAN	45MG	TABLET;ORAL	Prescription	No	AB	218381	APOTEX
TOLVAPTAN	TOLVAPTAN	45MG	TABLET;ORAL	Prescription	No	AB	216063	LUPIN LTD

TABLET;ORAL; 60MG
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JYNARQUE	TOLVAPTAN	60MG	TABLET;ORAL	Prescription	Yes	AB2	204441	OTSUKA
TOLVAPTAN	TOLVAPTAN	60MG	TABLET;ORAL	Prescription	No	AB2	218381	APOTEX
TOLVAPTAN	TOLVAPTAN	60MG	TABLET;ORAL	Prescription	No	AB2	216063	LUPIN LTD

TABLET;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
JYNARQUE	TOLVAPTAN	90MG	TABLET;ORAL	Prescription	Yes	AB	204441	OTSUKA
TOLVAPTAN	TOLVAPTAN	90MG	TABLET;ORAL	Prescription	No	AB	218381	APOTEX
TOLVAPTAN	TOLVAPTAN	90MG	TABLET;ORAL	Prescription	No	AB	216063	LUPIN LTD

Top