Application 215498

Type: NDA
Sponsor: ALBIREO PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BYLVAY	ODEVIXIBAT	CAPSULE;ORAL	400MCG	No	No
002	BYLVAY	ODEVIXIBAT	CAPSULE;ORAL	1200MCG	No	No
003	BYLVAY	ODEVIXIBAT	PELLETS;ORAL	200MCG	No	No
004	BYLVAY	ODEVIXIBAT	PELLETS;ORAL	600MCG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215498-001	BYLVAY	ODEVIXIBAT	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20
N215498-002	BYLVAY	ODEVIXIBAT	0.4MG	CAPSULE / ORAL	RLD	2021-07-20
N215498-003	BYLVAY	ODEVIXIBAT	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20
N215498-004	BYLVAY	ODEVIXIBAT	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20

Orange Book patents#

Current patent rows page 1 of 2 · 112 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215498-001	10011633	2031-11-08	U-3186		2021-08-18
N215498-001	10011633	2031-11-08	U-3648		2021-08-18
N215498-001	10093697	2031-11-08	U-3186		2021-08-18
N215498-001	10093697	2031-11-08	U-3648		2021-08-18
N215498-001	10487111	2031-11-08	U-3186		2021-08-18
N215498-001	10487111	2031-11-08	U-3648		2021-08-18
N215498-001	10981952	2031-11-08	U-3186		2021-08-18
N215498-001	10981952	2031-11-08	U-3187		2021-08-18
N215498-001	10981952	2031-11-08	U-3648		2021-08-18
N215498-001	10981952	2031-11-08	U-3649		2021-08-18
N215498-001	11732006	2031-11-08	U-3186		2023-09-21
N215498-001	11732006	2031-11-08	U-3648		2023-09-21
N215498-001	12187812	2031-11-08	U-3186		2025-02-11
N215498-001	12187812	2031-11-08	U-3648		2025-02-11
N215498-001	12545705	2031-11-08	U-3186		2026-03-06
N215498-001	12545705	2031-11-08	U-3648		2026-03-06
N215498-001	9694018	2034-03-18	U-3186		2021-08-18
N215498-001	9694018	2034-03-18	U-3648		2021-08-18
N215498-001	10975046	2039-06-20		Drug substance	2021-08-18
N215498-001	11365182	2039-06-20	U-3186		2022-07-12
N215498-001	11365182	2039-06-20	U-3648		2022-07-12
N215498-001	11801226	2039-06-20		Drug product	2023-11-29
N215498-001	11802115	2039-06-20		Drug product	2023-11-29
N215498-001	12091394	2039-06-20		Drug substance	2024-10-17
N215498-001	12508234	2039-06-20	U-3186		2026-01-27
N215498-001	12508234	2039-06-20	U-3648		2026-01-27
N215498-001	11583539	2041-11-12	U-3186		2023-03-20
N215498-001	12447156	2041-11-12	U-3186		2025-11-19
N215498-002	10011633	2031-11-08	U-3186		2021-08-18
N215498-002	10011633	2031-11-08	U-3648		2021-08-18
N215498-002	10093697	2031-11-08	U-3186		2021-08-18
N215498-002	10093697	2031-11-08	U-3648		2021-08-18
N215498-002	10487111	2031-11-08	U-3186		2021-08-18
N215498-002	10487111	2031-11-08	U-3648		2021-08-18
N215498-002	10981952	2031-11-08	U-3186		2021-08-18
N215498-002	10981952	2031-11-08	U-3187		2021-08-18
N215498-002	10981952	2031-11-08	U-3648		2021-08-18
N215498-002	10981952	2031-11-08	U-3649		2021-08-18
N215498-002	11732006	2031-11-08	U-3186		2023-09-21
N215498-002	11732006	2031-11-08	U-3648		2023-09-21
N215498-002	12187812	2031-11-08	U-3186		2025-02-11
N215498-002	12187812	2031-11-08	U-3648		2025-02-11
N215498-002	12545705	2031-11-08	U-3186		2026-03-06
N215498-002	12545705	2031-11-08	U-3648		2026-03-06
N215498-002	9694018	2034-03-18	U-3186		2021-08-18
N215498-002	9694018	2034-03-18	U-3648		2021-08-18
N215498-002	10975046	2039-06-20		Drug substance	2021-08-18
N215498-002	11365182	2039-06-20	U-3186		2022-07-12
N215498-002	11365182	2039-06-20	U-3648		2022-07-12
N215498-002	11801226	2039-06-20		Drug product	2023-11-29
N215498-002	11802115	2039-06-20		Drug product	2023-11-29
N215498-002	12091394	2039-06-20		Drug substance	2024-10-17
N215498-002	12508234	2039-06-20	U-3186		2026-01-27
N215498-002	12508234	2039-06-20	U-3648		2026-01-27
N215498-002	11583539	2041-11-12	U-3186		2023-03-20
N215498-002	12447156	2041-11-12	U-3186		2025-11-19
N215498-003	10011633	2031-11-08	U-3186		2021-08-18
N215498-003	10011633	2031-11-08	U-3648		2021-08-18
N215498-003	10093697	2031-11-08	U-3186		2021-08-18
N215498-003	10093697	2031-11-08	U-3648		2021-08-18
N215498-003	10487111	2031-11-08	U-3186		2021-08-18
N215498-003	10487111	2031-11-08	U-3648		2021-08-18
N215498-003	10981952	2031-11-08	U-3186		2021-08-18
N215498-003	10981952	2031-11-08	U-3187		2021-08-18
N215498-003	10981952	2031-11-08	U-3648		2021-08-18
N215498-003	10981952	2031-11-08	U-3649		2021-08-18
N215498-003	11732006	2031-11-08	U-3186		2023-09-21
N215498-003	11732006	2031-11-08	U-3648		2023-09-21
N215498-003	12187812	2031-11-08	U-3186		2025-02-11
N215498-003	12187812	2031-11-08	U-3648		2025-02-11
N215498-003	12545705	2031-11-08	U-3186		2026-03-06
N215498-003	12545705	2031-11-08	U-3648		2026-03-06
N215498-003	9694018	2034-03-18	U-3186		2021-08-18
N215498-003	9694018	2034-03-18	U-3648		2021-08-18
N215498-003	10975046	2039-06-20		Drug substance	2021-08-18
N215498-003	11365182	2039-06-20	U-3186		2022-07-12
N215498-003	11365182	2039-06-20	U-3648		2022-07-12
N215498-003	11801226	2039-06-20		Drug product	2023-11-29
N215498-003	11802115	2039-06-20		Drug product	2023-11-29
N215498-003	12091394	2039-06-20		Drug substance	2024-10-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 16 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215498-001	I-918	2026-06-13
N215498-001	NCE	2026-07-20
N215498-001	ODE-363	2028-07-20
N215498-001	ODE-436	2030-06-13
N215498-002	I-918	2026-06-13
N215498-002	NCE	2026-07-20
N215498-002	ODE-363	2028-07-20
N215498-002	ODE-436	2030-06-13
N215498-003	I-918	2026-06-13
N215498-003	NCE	2026-07-20
N215498-003	ODE-363	2028-07-20
N215498-003	ODE-436	2030-06-13
N215498-004	I-918	2026-06-13
N215498-004	NCE	2026-07-20
N215498-004	ODE-363	2028-07-20
N215498-004	ODE-436	2030-06-13

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 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 77 · 3,056 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	N215498-001	10011633	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10011633	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10093697	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10093697	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10487111	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10487111	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3187		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3649		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11732006	2031-11-08	U-3648		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11732006	2031-11-08	U-3186		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12187812	2031-11-08	U-3186		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12187812	2031-11-08	U-3648		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	9694018	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	9694018	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10975046	2039-06-20		Drug substance	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11365182	2039-06-20	U-3648		2022-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11365182	2039-06-20	U-3186		2022-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11801226	2039-06-20		Drug product	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11802115	2039-06-20		Drug product	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12091394	2039-06-20		Drug substance	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12508234	2039-06-20	U-3186		2026-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12508234	2039-06-20	U-3648		2026-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11583539	2041-11-12	U-3186		2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12447156	2041-11-12	U-3186		2025-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10011633	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10011633	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10093697	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10093697	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10487111	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10487111	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3187		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3649		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	11732006	2031-11-08	U-3648		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	11732006	2031-11-08	U-3186		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	12187812	2031-11-08	U-3186		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	12187812	2031-11-08	U-3648		2025-02-11	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 424 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215498-001	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	ODE-436	2030-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	ODE-436	2030-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215498-001	I-918	2026-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	NCE	2026-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	ODE-363	2028-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	ODE-436	2030-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	I-918	2026-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	NCE	2026-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	ODE-363	2028-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	ODE-436	2030-06-13	`6a471c1ec25d…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BYLVAY	ODEVIXIBAT	Albireo Pharma, Inc.	151f1d3e-2bf4-47ce-b1be-a892de3258fa	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215498 application number: NDA215498 ndc (product): 74528-040 ndc (product): 74528-020 ndc (product): 74528-060 ndc (product): 74528-120
Bylvay	ODEVIXIBAT	Ipsen Biopharmaceuticals, Inc.	0935cd31-3251-4a0a-ac23-25ca4be12be9	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215498 application number: NDA215498

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
74528-020	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-020	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-020	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-040	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-040	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-040	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-060	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-060	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-060	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-120	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-120	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current
74528-120	BYLVAY	odevixibat	Albireo Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84513	SUPPL	2025-12-23
84506	SUPPL	2025-12-23
81673	SUPPL	2025-03-21
81672	SUPPL	2025-03-21
74493	SUPPL	2023-06-15
74489	SUPPL	2023-06-14
74196	SUPPL	2023-05-09
74193	SUPPL	2023-05-09
72468	SUPPL	2022-10-26
72452	SUPPL	2022-10-24
68404	ORIG	2021-08-18
68148	ORIG	2021-07-21
68140	ORIG	2021-07-21