Application 208573

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENCLEXTA	VENETOCLAX	TABLET;ORAL	10MG	Yes	No
002	VENCLEXTA	VENETOCLAX	TABLET;ORAL	50MG	Yes	No
003	VENCLEXTA	VENETOCLAX	TABLET;ORAL	100MG	Yes	Yes

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
N208573-001	VENCLEXTA	VENETOCLAX	10MG	TABLET / ORAL	AB	RLD	2016-04-11
N208573-002	VENCLEXTA	VENETOCLAX	50MG	TABLET / ORAL	AB	RLD	2016-04-11
N208573-003	VENCLEXTA	VENETOCLAX	100MG	TABLET / ORAL	AB	RLD, RS	2016-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N208573-001	AB
N208573-002	AB
N208573-003	AB

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
N208573-001	9174982	2030-05-26	U-2323		2016-05-04
N208573-001	9174982	2030-05-26	U-2445		2016-05-04
N208573-001	9174982	2030-05-26	U-2446		2016-05-04
N208573-001	9174982	2030-05-26	U-2537		2016-05-04
N208573-001	8546399	2031-06-27		Drug substance, Drug product	2016-05-04
N208573-001	10730873	2031-11-21		Drug substance	2020-08-17
N208573-001	8722657	2032-01-29		Drug substance	2020-02-13
N208573-001	11369599	2032-05-23		Drug product	2022-07-20
N208573-001	10993942	2033-09-06	U-3114		2021-05-24
N208573-001	11110087	2033-09-06	U-3222		2021-10-07
N208573-001	11110087	2033-09-06	U-3223		2021-10-07
N208573-001	11413282	2033-09-06	U-3412		2022-09-12
N208573-001	11590128	2033-09-06	U-3548		2023-03-24
N208573-001	9539251	2033-09-06	U-2538		2019-06-13
N208573-002	9174982	2030-05-26	U-2323		2016-05-04
N208573-002	9174982	2030-05-26	U-2445		2016-05-04
N208573-002	9174982	2030-05-26	U-2446		2016-05-04
N208573-002	9174982	2030-05-26	U-2537		2016-05-04
N208573-002	8546399	2031-06-27		Drug substance, Drug product	2016-05-04
N208573-002	10730873	2031-11-21		Drug substance	2020-08-17
N208573-002	8722657	2032-01-29		Drug substance	2020-02-13
N208573-002	11369599	2032-05-23		Drug product	2022-07-20
N208573-002	10993942	2033-09-06	U-3114		2021-05-24
N208573-002	11110087	2033-09-06	U-3222		2021-10-07
N208573-002	11110087	2033-09-06	U-3223		2021-10-07
N208573-002	11413282	2033-09-06	U-3412		2022-09-12
N208573-002	11590128	2033-09-06	U-3548		2023-03-24
N208573-002	9539251	2033-09-06	U-2538		2019-06-13
N208573-003	9174982	2030-05-26	U-2323		2016-05-04
N208573-003	9174982	2030-05-26	U-2445		2016-05-04
N208573-003	9174982	2030-05-26	U-2446		2016-05-04
N208573-003	9174982	2030-05-26	U-2537		2016-05-04
N208573-003	8546399	2031-06-27		Drug substance, Drug product	2016-05-04
N208573-003	10730873	2031-11-21		Drug substance	2020-08-17
N208573-003	8722657	2032-01-29		Drug substance	2020-02-13
N208573-003	11369599	2032-05-23		Drug product	2022-07-20
N208573-003	10993942	2033-09-06	U-3114		2021-05-24
N208573-003	11110087	2033-09-06	U-3222		2021-10-07
N208573-003	11110087	2033-09-06	U-3223		2021-10-07
N208573-003	11413282	2033-09-06	U-3412		2022-09-12
N208573-003	11590128	2033-09-06	U-3548		2023-03-24
N208573-003	9539251	2033-09-06	U-2538		2019-06-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208573-001	ODE-239	2026-05-15
N208573-002	ODE-239	2026-05-15
N208573-003	ODE-239	2026-05-15

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 · 123 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	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208573-002	VENCLEXTA	50MG	TABLET / ORAL	RLD	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208573-003	VENCLEXTA	100MG	TABLET / ORAL	RLD, RS	2016-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208573-001	VENCLEXTA	10MG	TABLET / ORAL	RLD	2016-04-11	`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	N208573-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208573-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208573-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 38 · 1,494 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	N208573-001	9174982	2030-05-26	U-2537		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	9174982	2030-05-26	U-2445		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	9174982	2030-05-26	U-2323		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	9174982	2030-05-26	U-2446		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	8546399	2031-06-27		Drug substance, Drug product	2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	10730873	2031-11-21		Drug substance	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	8722657	2032-01-29		Drug substance	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	11369599	2032-05-23		Drug product	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	10993942	2033-09-06	U-3114		2021-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	11110087	2033-09-06	U-3222		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	11110087	2033-09-06	U-3223		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	11413282	2033-09-06	U-3412		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	11590128	2033-09-06	U-3548		2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-001	9539251	2033-09-06	U-2538		2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	9174982	2030-05-26	U-2323		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	9174982	2030-05-26	U-2537		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	9174982	2030-05-26	U-2446		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	9174982	2030-05-26	U-2445		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	8546399	2031-06-27		Drug substance, Drug product	2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	10730873	2031-11-21		Drug substance	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	8722657	2032-01-29		Drug substance	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	11369599	2032-05-23		Drug product	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	10993942	2033-09-06	U-3114		2021-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	11110087	2033-09-06	U-3222		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	11110087	2033-09-06	U-3223		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	11413282	2033-09-06	U-3412		2022-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	11590128	2033-09-06	U-3548		2023-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	9539251	2033-09-06	U-2538		2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	9174982	2030-05-26	U-2537		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	9174982	2030-05-26	U-2445		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	9174982	2030-05-26	U-2446		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	9174982	2030-05-26	U-2323		2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	8546399	2031-06-27		Drug substance, Drug product	2016-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	10730873	2031-11-21		Drug substance	2020-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	8722657	2032-01-29		Drug substance	2020-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	11369599	2032-05-23		Drug product	2022-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	10993942	2033-09-06	U-3114		2021-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	11110087	2033-09-06	U-3222		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	11110087	2033-09-06	U-3223		2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	11413282	2033-09-06	U-3412		2022-09-12	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 648 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	N208573-001	ODE-239	2026-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-002	ODE-239	2026-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208573-003	ODE-239	2026-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-001	ODE-185	2025-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-001	ODE-211	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-001	ODE-239	2026-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-002	ODE-185	2025-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-002	ODE-211	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-002	ODE-239	2026-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-003	ODE-185	2025-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-003	ODE-211	2025-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208573-003	ODE-239	2026-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208573-001	ODE-185	2025-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-001	ODE-211	2025-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-001	ODE-239	2026-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-002	ODE-185	2025-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-002	ODE-211	2025-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-002	ODE-239	2026-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-003	ODE-185	2025-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-003	ODE-211	2025-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208573-003	ODE-239	2026-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-001	ODE-185	2025-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-001	ODE-211	2025-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-001	ODE-239	2026-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-002	ODE-185	2025-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-002	ODE-211	2025-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-002	ODE-239	2026-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-003	ODE-185	2025-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-003	ODE-211	2025-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208573-003	ODE-239	2026-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-001	ODE-185	2025-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-001	ODE-211	2025-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-001	ODE-239	2026-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-002	ODE-185	2025-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-002	ODE-211	2025-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-002	ODE-239	2026-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-003	ODE-185	2025-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-003	ODE-211	2025-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208573-003	ODE-239	2026-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208573-001	ODE-185	2025-06-08	`03ed91905a0d…`

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
Venclexta	VENETOCLAX	AbbVie Inc.	b118a40d-6b56-cee3-10f6-ded821a97018	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208573 application number: NDA208573 ndc (product): 0074-0561 ndc (product): 0074-0576 ndc (product): 0074-0579 ndc (product): 0074-0566

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
86012	SUPPL	2026-05-22
86002	SUPPL	2026-05-21
85129	SUPPL	2026-02-24
85099	SUPPL	2026-02-23
71341	SUPPL	2022-06-16
71337	SUPPL	2022-06-16
69109	SUPPL	2021-10-25
69108	SUPPL	2021-10-25
69087	SUPPL	2021-10-25
68892	SUPPL	2021-10-06
68876	SUPPL	2021-10-05
65545	SUPPL	2020-12-09
65544	SUPPL	2020-12-09
65487	SUPPL	2020-12-02
65302	SUPPL	2020-11-23
65296	SUPPL	2020-11-20
64941	SUPPL	2020-10-20
64940	SUPPL	2020-10-20
64932	SUPPL	2020-10-16
64931	SUPPL	2020-10-16
64929	SUPPL	2020-10-16
63710	SUPPL	2020-06-26
63563	SUPPL	2020-06-15
63396	SUPPL	2020-06-02
63395	SUPPL	2020-06-02
63385	SUPPL	2020-06-02
60159	SUPPL	2019-09-30
59490	SUPPL	2019-07-29
59489	SUPPL	2019-07-29
59488	SUPPL	2019-07-29
59487	SUPPL	2019-07-29
59486	SUPPL	2019-07-29
59485	SUPPL	2019-07-29
59467	SUPPL	2019-07-26
59466	SUPPL	2019-07-26
59465	SUPPL	2019-07-26
58750	SUPPL	2019-05-16
58734	SUPPL	2019-05-15
56719	SUPPL	2018-12-12
56530	SUPPL	2018-11-21
55447	SUPPL	2018-09-12
55446	SUPPL	2018-09-12
55428	SUPPL	2018-09-11
55427	SUPPL	2018-09-11
54591	SUPPL	2018-06-14
54590	SUPPL	2018-06-14
54480	SUPPL	2018-06-08
54479	SUPPL	2018-06-08
50852	SUPPL	2017-12-26
43550	ORIG	2016-05-19
24536	ORIG	2016-05-19
32912	ORIG	2016-04-11
19998	ORIG	2016-04-11