Application 210854

Type: NDA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XOFLUZA	BALOXAVIR MARBOXIL	TABLET;ORAL	20MG	Yes	No
002	XOFLUZA	BALOXAVIR MARBOXIL	TABLET;ORAL	40MG	Yes	Yes
003	XOFLUZA	BALOXAVIR MARBOXIL	TABLET;ORAL	80MG	Yes	No

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

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	TE codes	RLD / RS	Approval date
N210854-001	XOFLUZA	BALOXAVIR MARBOXIL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2018-10-24
N210854-002	XOFLUZA	BALOXAVIR MARBOXIL	40MG	TABLET / ORAL	AB	RLD	2018-10-24
N210854-003	XOFLUZA	BALOXAVIR MARBOXIL	80MG	TABLET / ORAL	AB	RLD, RS	2021-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N210854-002	AB
N210854-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210854-001	9815835	2030-06-14		Drug product	2018-11-16
N210854-001	8927710	2031-05-05		Drug product	2018-11-16
N210854-001	8987441	2032-10-24		Drug substance, Drug product	2018-11-16
N210854-001	10392406	2036-04-27		Drug substance	2019-09-20
N210854-001	10633397	2036-04-27	U-2816		2020-05-26
N210854-001	10633397	2036-04-27	U-3000		2020-05-26
N210854-001	10759814	2037-08-09		Drug substance, Drug product	2020-12-17
N210854-001	11306106	2037-08-09	U-2816		2022-05-17
N210854-001	11306106	2037-08-09	U-3000		2022-05-17
N210854-001	11261198	2038-09-25		Drug product	2022-04-04
N210854-001	12064438	2039-10-09		Drug product	2024-09-16
N210854-002	9815835	2030-06-14		Drug product	2018-11-16
N210854-002	8927710	2031-05-05		Drug product	2018-11-16
N210854-002	8987441	2032-10-24		Drug substance, Drug product	2018-11-16
N210854-002	10392406	2036-04-27		Drug substance	2019-09-20
N210854-002	10633397	2036-04-27	U-2816		2020-05-26
N210854-002	10633397	2036-04-27	U-3000		2020-05-26
N210854-002	10759814	2037-08-09		Drug substance, Drug product	2020-12-17
N210854-002	11306106	2037-08-09	U-2816		2022-05-17
N210854-002	11306106	2037-08-09	U-3000		2022-05-17
N210854-002	11261198	2038-09-25		Drug product	2022-04-04
N210854-002	12064438	2039-10-09		Drug product	2024-09-16
N210854-003	9815835	2030-06-14		Drug product	2021-08-11
N210854-003	8927710	2031-05-05		Drug product	2021-08-11
N210854-003	8987441	2032-10-24		Drug substance, Drug product	2021-08-11
N210854-003	10392406	2036-04-27		Drug substance	2021-08-11
N210854-003	10633397	2036-04-27	U-2816		2021-08-11
N210854-003	10633397	2036-04-27	U-3000		2021-08-11
N210854-003	10759814	2037-08-09		Drug substance, Drug product	2021-08-11
N210854-003	11306106	2037-08-09	U-2816		2022-05-17
N210854-003	11306106	2037-08-09	U-3000		2022-05-17
N210854-003	11261198	2038-09-25		Drug product	2022-04-04
N210854-003	12064438	2039-10-09		Drug product	2024-09-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210854-001	M-187	2027-12-19
N210854-002	M-187	2027-12-19
N210854-003	M-187	2027-12-19

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 3 · 116 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	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210854-002	XOFLUZA	40MG	TABLET / ORAL	RLD	2018-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210854-003	XOFLUZA	80MG	TABLET / ORAL	RLD, RS	2021-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210854-001	XOFLUZA	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2018-10-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210854-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210854-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,063 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	N210854-001	9815835	2030-06-14		Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	8927710	2031-05-05		Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	8987441	2032-10-24		Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	10392406	2036-04-27		Drug substance	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	10633397	2036-04-27	U-2816		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	10633397	2036-04-27	U-3000		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	10759814	2037-08-09		Drug substance, Drug product	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	11306106	2037-08-09	U-2816		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	11306106	2037-08-09	U-3000		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	11261198	2038-09-25		Drug product	2022-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-001	12064438	2039-10-09		Drug product	2024-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	9815835	2030-06-14		Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	8927710	2031-05-05		Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	8987441	2032-10-24		Drug substance, Drug product	2018-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	10392406	2036-04-27		Drug substance	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	10633397	2036-04-27	U-2816		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	10633397	2036-04-27	U-3000		2020-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	10759814	2037-08-09		Drug substance, Drug product	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	11306106	2037-08-09	U-2816		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	11306106	2037-08-09	U-3000		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	11261198	2038-09-25		Drug product	2022-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	12064438	2039-10-09		Drug product	2024-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	9815835	2030-06-14		Drug product	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	8927710	2031-05-05		Drug product	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	8987441	2032-10-24		Drug substance, Drug product	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	10392406	2036-04-27		Drug substance	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	10633397	2036-04-27	U-3000		2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	10633397	2036-04-27	U-2816		2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	10759814	2037-08-09		Drug substance, Drug product	2021-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	11306106	2037-08-09	U-2816		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	11306106	2037-08-09	U-3000		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	11261198	2038-09-25		Drug product	2022-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	12064438	2039-10-09		Drug product	2024-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	9815835	2030-06-14		Drug product	2018-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	8927710	2031-05-05		Drug product	2018-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	8987441	2031-09-21		Drug substance, Drug product	2018-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	10392406	2036-04-27		Drug substance	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	10633397	2036-04-27	U-2816		2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	10633397	2036-04-27	U-3000		2020-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	10759814	2037-08-09		Drug substance, Drug product	2020-12-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 123 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	N210854-001	M-187	2027-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-002	M-187	2027-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210854-003	M-187	2027-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-001	M-187	2027-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-002	M-187	2027-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210854-003	M-187	2027-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210854-001	M-187	2027-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-002	M-187	2027-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210854-003	M-187	2027-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-001	M-187	2027-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-002	M-187	2027-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210854-003	M-187	2027-12-19	`fd3edfee7708…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-001	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-001	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-002	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-002	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-003	I-811	2022-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210854-003	NCE	2023-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210854-001	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-001	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-002	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-002	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-003	I-811	2022-10-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210854-003	NCE	2023-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210854-001	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-001	NCE	2023-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-002	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-002	NCE	2023-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-003	I-811	2022-10-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210854-003	NCE	2023-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210854-001	I-811	2022-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-001	NCE	2023-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-002	I-811	2022-10-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210854-002	NCE	2023-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210854-001	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-001	NCE	2023-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-002	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-002	NCE	2023-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-003	I-811	2022-10-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210854-003	NCE	2023-10-24	`bb7c543d1eb4…`

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
Xofluza	BALOXAVIR MARBOXIL	Sportpharm LLC	b58b2899-4d22-41e1-8f0c-bdead8917694	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210854 application number: NDA210854
Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	e49e1a61-1b7c-4be5-ac84-af6240b511e7	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210854 application number: NDA210854 ndc (product): 50242-583 ndc (product): 50242-860 ndc (product): 50242-877

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4102	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50090-4102	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50090-4102	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50090-4104	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50090-4104	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50090-4104	Xofluza	BALOXAVIR MARBOXIL	A-S Medication Solutions	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-583	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-828	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc	NDA	Current
50242-860	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-877	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-877	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-877	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-877	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current
50242-877	Xofluza	BALOXAVIR MARBOXIL	Genentech, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82429	SUPPL	2026-04-27
83422	SUPPL	2025-09-23
82422	SUPPL	2025-06-02
80682	SUPPL	2024-12-23
80668	SUPPL	2024-12-20
77706	SUPPL	2024-03-04
77692	SUPPL	2024-03-04
74532	SUPPL	2023-06-16
74511	SUPPL	2023-06-16
71801	SUPPL	2022-08-15
71800	SUPPL	2022-08-15
71792	SUPPL	2022-08-12
71791	SUPPL	2022-08-12
66083	SUPPL	2021-02-03
66082	SUPPL	2021-02-03
65348	SUPPL	2020-11-25
65347	SUPPL	2020-11-25
65325	SUPPL	2020-11-25
65324	SUPPL	2020-11-25
61082	SUPPL	2019-11-27
60576	SUPPL	2019-10-17
60578	SUPPL	2019-10-16
56648	ORIG	2018-12-07
56095	ORIG	2018-10-25
56094	ORIG	2018-10-25