Application 204819

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADEMPAS	RIOCIGUAT	TABLET;ORAL	0.5MG	Yes	No
002	ADEMPAS	RIOCIGUAT	TABLET;ORAL	1MG	Yes	No
003	ADEMPAS	RIOCIGUAT	TABLET;ORAL	1.5MG	Yes	No
004	ADEMPAS	RIOCIGUAT	TABLET;ORAL	2MG	Yes	No
005	ADEMPAS	RIOCIGUAT	TABLET;ORAL	2.5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N204819-001	ADEMPAS	RIOCIGUAT	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-002	ADEMPAS	RIOCIGUAT	1MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-003	ADEMPAS	RIOCIGUAT	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-004	ADEMPAS	RIOCIGUAT	2MG	TABLET / ORAL	AB	RLD	2013-10-08
N204819-005	ADEMPAS	RIOCIGUAT	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204819-001	AB
N204819-002	AB
N204819-003	AB
N204819-004	AB
N204819-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 35 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204819-001	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-001	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-001	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-001	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-001	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-001	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-001	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-002	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-002	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-002	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-002	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-002	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-002	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-002	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-003	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-003	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-003	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-003	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-003	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-003	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-003	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-004	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-004	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-004	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-004	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-004	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-004	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-004	12503469	2034-02-18	U-2835	Drug product	2026-01-21
N204819-005	7173037	2026-12-04		Drug substance, Drug product	2013-11-06
N204819-005	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23
N204819-005	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23
N204819-005	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14
N204819-005	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14
N204819-005	12503469	2034-02-18	U-2834	Drug product	2026-01-21
N204819-005	12503469	2034-02-18	U-2835	Drug product	2026-01-21

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 · 205 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
2026-02-19 14:30 UTC	2026-02	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-001	ADEMPAS	0.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-002	ADEMPAS	1MG	TABLET / ORAL	AB	RLD	2013-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-003	ADEMPAS	1.5MG	TABLET / ORAL	AB	RLD	2013-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-004	ADEMPAS	2MG	TABLET / ORAL	AB	RLD	2013-10-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-005	ADEMPAS	2.5MG	TABLET / ORAL	AB	RLD, RS	2013-10-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204819-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204819-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204819-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204819-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204819-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204819-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204819-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204819-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 935 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204819-001	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-001	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-002	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-003	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-004	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	12503469	2034-02-18	U-2834	Drug product	2026-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204819-005	12503469	2034-02-18	U-2835	Drug product	2026-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	7173037	2026-12-04		Drug substance, Drug product	2013-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	10662188	2034-02-18	U-2834	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	10662188	2034-02-18	U-2835	Drug substance, Drug product	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	11203593	2034-02-18	U-2834	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204819-001	11203593	2034-02-18	U-2835	Drug substance, Drug product	2022-01-14	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204819-001	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-002	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-003	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-004	ODE-53	2020-10-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204819-005	ODE-53	2020-10-08	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204819-001	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-002	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-003	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-004	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204819-005	ODE-53	2020-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204819-001	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-002	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-003	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-004	ODE-53	2020-10-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204819-005	ODE-53	2020-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204819-001	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-002	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-003	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-004	ODE-53	2020-10-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204819-005	ODE-53	2020-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204819-001	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-002	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-003	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-004	ODE-53	2020-10-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204819-005	ODE-53	2020-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204819-001	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-002	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-003	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-004	ODE-53	2020-10-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204819-005	ODE-53	2020-10-08	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Adempas	RIOCIGUAT	Bayer HealthCare Pharmaceuticals Inc.	7b57509a-3d5d-41d4-8fed-1471e26372a3	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204819 application number: NDA204819 ndc (product): 50419-253 ndc (product): 50419-251 ndc (product): 50419-250 ndc (product): 50419-254 ndc (product): 50419-252

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-250	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-251	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-252	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-253	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-254	Adempas	riociguat	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85869	SUPPL	2026-05-11
76283	ORIG	2023-11-03
68614	SUPPL	2021-09-14
68600	SUPPL	2021-09-13
68599	SUPPL	2021-09-13
65464	SUPPL	2020-12-02
61868	SUPPL	2020-02-12
56697	SUPPL	2018-12-10
51072	SUPPL	2018-01-17
51056	SUPPL	2018-01-17
47416	SUPPL	2017-03-02
47326	SUPPL	2017-02-24
47206	SUPPL	2017-02-15
46962	SUPPL	2017-01-24
46904	SUPPL	2017-01-19
45504	SUPPL	2016-10-06
10400	SUPPL	2015-12-07
10398	SUPPL	2014-06-12
40425	SUPPL	2014-05-12
10399	SUPPL	2014-05-08
44911	ORIG	2013-11-05
22966	ORIG	2013-11-05
40424	ORIG	2013-10-17
44594	ORIG	2013-10-15
32595	ORIG	2013-10-10