Application 215192

Type: NDA
Sponsor: AKEBIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VAFSEO	VADADUSTAT	TABLET;ORAL	150MG	Yes	No
002	VAFSEO	VADADUSTAT	TABLET;ORAL	300MG	Yes	No
003	VAFSEO	VADADUSTAT	TABLET;ORAL	450MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215192-001	VAFSEO	VADADUSTAT	150MG	TABLET / ORAL	RLD	2024-03-27
N215192-002	VAFSEO	VADADUSTAT	300MG	TABLET / ORAL	RLD	2024-03-27
N215192-003	VAFSEO	VADADUSTAT	450MG	TABLET / ORAL	RLD	2024-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215192-001	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-001	8940773	2027-06-26	U-3876		2024-04-10
N215192-001	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-001	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-001	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-001	8323671	2028-04-03	U-3876		2024-04-10
N215192-001	12569474	2034-06-04	U-3876		2026-03-25
N215192-001	11857543	2034-06-09	U-3876		2024-04-10
N215192-001	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-001	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-001	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-001	9987262	2034-11-14	U-3876		2024-04-10
N215192-001	11324734	2036-03-31		Drug product	2024-04-10
N215192-001	11844756	2036-03-31	U-3876		2024-04-10
N215192-002	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-002	8940773	2027-06-26	U-3876		2024-04-10
N215192-002	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-002	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-002	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-002	8323671	2028-04-03	U-3876		2024-04-10
N215192-002	12569474	2034-06-04	U-3876		2026-03-25
N215192-002	11857543	2034-06-09	U-3876		2024-04-10
N215192-002	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-002	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-002	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-002	9987262	2034-11-14	U-3876		2024-04-10
N215192-002	11324734	2036-03-31		Drug product	2024-04-10
N215192-002	11844756	2036-03-31	U-3876		2024-04-10
N215192-003	8598210	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-003	8940773	2027-06-26	U-3876		2024-04-10
N215192-003	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10
N215192-003	8343952	2027-08-14		Drug substance, Drug product	2024-04-10
N215192-003	7811595	2028-03-13		Drug substance, Drug product	2024-04-10
N215192-003	8323671	2028-04-03	U-3876		2024-04-10
N215192-003	12569474	2034-06-04	U-3876		2026-03-25
N215192-003	11857543	2034-06-09	U-3876		2024-04-10
N215192-003	10149842	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-003	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10
N215192-003	9701636	2034-11-14		Drug substance, Drug product	2024-04-10
N215192-003	9987262	2034-11-14	U-3876		2024-04-10
N215192-003	11324734	2036-03-31		Drug product	2024-04-10
N215192-003	11844756	2036-03-31	U-3876		2024-04-10

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215192-001	NCE	2029-03-27
N215192-002	NCE	2029-03-27
N215192-003	NCE	2029-03-27

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 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD	2024-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD	2024-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-002	VAFSEO	300MG	TABLET / ORAL	RLD	2024-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-003	VAFSEO	450MG	TABLET / ORAL	RLD, RS	2024-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215192-001	VAFSEO	150MG	TABLET / ORAL	RLD	2024-03-27	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 714 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11324734	2036-03-31		Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-001	11844756	2036-03-31	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11324734	2036-03-31		Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	11844756	2036-03-31	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8598210	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8940773	2027-06-26	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	RE47437	2027-06-26		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8343952	2027-08-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	7811595	2028-03-13		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	8323671	2028-04-03	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	12569474	2034-06-04	U-3876		2026-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	11857543	2034-06-09	U-3876		2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	10149842	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	11065237	2034-11-14	U-3876	Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	9701636	2034-11-14		Drug substance, Drug product	2024-04-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	9987262	2034-11-14	U-3876		2024-04-10	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N215192-001	NCE	2029-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-002	NCE	2029-03-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215192-003	NCE	2029-03-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215192-001	NCE	2029-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-002	NCE	2029-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215192-003	NCE	2029-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215192-001	NCE	2029-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-002	NCE	2029-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215192-003	NCE	2029-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215192-001	NCE	2029-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-002	NCE	2029-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215192-003	NCE	2029-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-001	NCE	2029-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-002	NCE	2029-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215192-003	NCE	2029-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215192-001	NCE	2029-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-002	NCE	2029-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215192-003	NCE	2029-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-001	NCE	2029-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-002	NCE	2029-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215192-003	NCE	2029-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-001	NCE	2029-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-002	NCE	2029-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215192-003	NCE	2029-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-001	NCE	2029-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-002	NCE	2029-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215192-003	NCE	2029-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-001	NCE	2029-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-002	NCE	2029-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215192-003	NCE	2029-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-001	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-002	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215192-003	NCE	2029-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-001	NCE	2029-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-002	NCE	2029-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215192-003	NCE	2029-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215192-001	NCE	2029-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-002	NCE	2029-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215192-003	NCE	2029-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215192-001	NCE	2029-03-27	`79d66fd596c7…`

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
VAFSEO	VADADUSTAT	Akebia Therapeutics, Inc.	ac9da724-5a62-4ab6-a89c-376a25f6195b	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215192 application number: NDA215192

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85634	SUPPL	2026-04-02
85633	SUPPL	2026-04-02
78206	ORIG	2024-04-23
78007	ORIG	2024-03-29
78006	ORIG	2024-03-29
78003	ORIG	2024-03-28