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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204441-001	JYNARQUE	TOLVAPTAN	15MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-002	JYNARQUE	TOLVAPTAN	30MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-003	JYNARQUE	TOLVAPTAN	45MG	TABLET / ORAL	AB2	RLD, RS	2018-04-23
N204441-004	JYNARQUE	TOLVAPTAN	60MG	TABLET / ORAL	AB2	RLD	2018-04-23
N204441-005	JYNARQUE	TOLVAPTAN	90MG	TABLET / ORAL	AB2	RLD	2018-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N204441-001	AB2
N204441-002	AB2
N204441-003	AB2
N204441-004	AB2
N204441-005	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204441-001	8501730	2026-09-01	Drug substance	2018-05-21
N204441-001	10905694	2030-04-07	Drug product	2021-02-26
N204441-002	8501730	2026-09-01	Drug substance	2018-05-21
N204441-002	10905694	2030-04-07	Drug product	2021-02-26
N204441-003	8501730	2026-09-01	Drug substance	2018-05-21
N204441-003	10905694	2030-04-07	Drug product	2021-02-26
N204441-004	8501730	2026-09-01	Drug substance	2018-05-21
N204441-004	10905694	2030-04-07	Drug product	2021-02-26
N204441-005	8501730	2026-09-01	Drug substance	2018-05-21
N204441-005	10905694	2030-04-07	Drug product	2021-02-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB2	RLD, RS	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB2	RLD	2018-04-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204441-001	JYNARQUE	15MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	JYNARQUE	30MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	JYNARQUE	45MG	TABLET / ORAL	AB	RLD, RS	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	JYNARQUE	60MG	TABLET / ORAL	AB2	RLD	2018-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	JYNARQUE	90MG	TABLET / ORAL	AB	RLD	2018-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-001	JYNARQUE	15MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-002	JYNARQUE	30MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-003	JYNARQUE	45MG	TABLET / ORAL		RLD, RS	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-004	JYNARQUE	60MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204441-005	JYNARQUE	90MG	TABLET / ORAL		RLD	2018-04-23	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N204441-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204441-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204441-005	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-001	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-002	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-004	AB2	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204441-005	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 425 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-001	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-002	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-003	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-004	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	8501730	2026-09-01	Drug substance	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204441-005	10905694	2030-04-07	Drug product	2021-02-26	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 6 · 240 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-10-29 15:01 UTC	2024-10	N204441-001	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-002	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-003	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-004	ODE-178	2025-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204441-005	ODE-178	2025-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-001	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-002	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-003	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-004	ODE-178	2025-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204441-005	ODE-178	2025-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-001	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-002	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-003	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-004	ODE-178	2025-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204441-005	ODE-178	2025-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-001	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-002	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-003	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-004	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204441-005	ODE-178	2025-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204441-001	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-002	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-003	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-004	ODE-178	2025-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204441-005	ODE-178	2025-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-001	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-002	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-003	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-004	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204441-005	ODE-178	2025-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204441-001	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-002	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-003	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-004	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204441-005	ODE-178	2025-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204441-001	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-002	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-003	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-004	ODE-178	2025-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204441-005	ODE-178	2025-04-23	`4b0b4de00fa7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	82ef58ef-ce46-434e-bf99-89fce51094f1	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Par Health USA, LLC	5b14ba2b-9f80-41d6-9613-f16d3cf37d25	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
SAMSCA	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	5526617c-c7b9-4556-886d-729bbabbc566	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Northstar Rx LLC	c075d517-f4c8-469a-9f51-416ef61c6a83	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Lupin Pharmaceuticals, Inc.	9ba38e23-ca66-4406-92af-bbb8fad00e16	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Teva Pharmaceuticals, Inc.	808a9a1f-2f58-4677-9127-e749ad007094	2025-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Novadoz Pharmaceuticals LLC	92ce12f1-eae0-4c83-9a4e-a5181e08fa92	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	dd71ee70-9435-4715-bee5-edbb5a8d7d7b	2022-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Camber Pharmaceuticals, Inc.	6f4c5679-8490-45ec-bd34-1a569e3af850	2022-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

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