Application 212306

Type: NDA
Sponsor: KARYOPHARM THERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XPOVIO	SELINEXOR	TABLET;ORAL	20MG	Yes	Yes
002	XPOVIO	SELINEXOR	TABLET;ORAL	40MG	Yes	No
003	XPOVIO	SELINEXOR	TABLET;ORAL	50MG	Yes	No
004	XPOVIO	SELINEXOR	TABLET;ORAL	60MG	Yes	No
005	XPOVIO	SELINEXOR	TABLET;ORAL	10MG	Yes	No
006	XPOVIO	SELINEXOR	TABLET;ORAL	80MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212306-001	XPOVIO	SELINEXOR	20MG	TABLET / ORAL	RLD	2019-07-03
N212306-002	XPOVIO	SELINEXOR	40MG	TABLET / ORAL	RLD	2021-04-15
N212306-003	XPOVIO	SELINEXOR	50MG	TABLET / ORAL	RLD	2021-04-15
N212306-004	XPOVIO	SELINEXOR	60MG	TABLET / ORAL	RLD, RS	2021-04-15
N212306-005	XPOVIO	SELINEXOR	10MG	TABLET / ORAL	RLD	2025-03-10
N212306-006	XPOVIO	SELINEXOR	80MG	TABLET / ORAL	RLD	2025-10-20

Orange Book patents#

Current patent rows page 1 of 2 · 115 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212306-001	10544108	2032-07-26	U-2584		2020-02-24
N212306-001	10544108	2032-07-26	U-3018		2020-02-24
N212306-001	11034660	2032-07-26	U-2584		2021-07-14
N212306-001	11034660	2032-07-26	U-3018		2021-07-14
N212306-001	11787771	2032-07-26	U-2584		2023-11-15
N212306-001	11787771	2032-07-26	U-2855		2023-11-15
N212306-001	11787771	2032-07-26	U-3018		2023-11-15
N212306-001	12291508	2032-07-26	U-2584		2025-06-04
N212306-001	12291508	2032-07-26	U-3018		2025-06-04
N212306-001	9079865	2032-07-26	U-2584		2019-07-31
N212306-001	9079865	2032-07-26	U-3018		2019-07-31
N212306-001	9714226	2032-07-26		Drug substance, Drug product	2019-07-31
N212306-001	8999996	2033-07-03		Drug substance, Drug product	2019-07-31
N212306-001	10519139	2035-08-14	U-2584	Drug substance, Drug product	2020-01-27
N212306-001	10519139	2035-08-14	U-3018	Drug substance, Drug product	2020-01-27
N212306-001	11746102	2035-08-14	U-2584		2023-10-04
N212306-001	11746102	2035-08-14	U-3018		2023-10-04
N212306-001	11753401	2035-08-14	U-2584	Drug product	2023-10-11
N212306-001	11753401	2035-08-14	U-3018	Drug product	2023-10-11
N212306-001	11807629	2035-08-14		Drug substance, Drug product	2023-12-06
N212306-002	10544108	2032-07-26	U-2584		2021-07-19
N212306-002	10544108	2032-07-26	U-3018		2021-07-19
N212306-002	11034660	2032-07-26	U-2584		2021-07-14
N212306-002	11034660	2032-07-26	U-3018		2021-07-14
N212306-002	11787771	2032-07-26	U-2584		2023-11-15
N212306-002	11787771	2032-07-26	U-3018		2023-11-15
N212306-002	12291508	2032-07-26	U-2584		2025-06-04
N212306-002	12291508	2032-07-26	U-3018		2025-06-04
N212306-002	9079865	2032-07-26	U-2584		2021-07-19
N212306-002	9079865	2032-07-26	U-3018		2021-07-19
N212306-002	9714226	2032-07-26		Drug substance, Drug product	2021-07-19
N212306-002	8999996	2033-07-03		Drug substance, Drug product	2021-07-19
N212306-002	10519139	2035-08-14	U-2584	Drug substance, Drug product	2021-07-19
N212306-002	10519139	2035-08-14	U-3018	Drug substance, Drug product	2021-07-19
N212306-002	11746102	2035-08-14	U-2584		2023-10-04
N212306-002	11746102	2035-08-14	U-3018		2023-10-04
N212306-002	11753401	2035-08-14	U-2584	Drug product	2023-10-11
N212306-002	11753401	2035-08-14	U-3018	Drug product	2023-10-11
N212306-002	11807629	2035-08-14		Drug substance, Drug product	2023-12-06
N212306-003	10544108	2032-07-26	U-2584		2021-07-19
N212306-003	10544108	2032-07-26	U-3018		2021-07-19
N212306-003	11034660	2032-07-26	U-2584		2021-07-14
N212306-003	11034660	2032-07-26	U-3018		2021-07-14
N212306-003	11787771	2032-07-26	U-2584		2023-11-15
N212306-003	11787771	2032-07-26	U-3018		2023-11-15
N212306-003	12291508	2032-07-26	U-2584		2025-06-04
N212306-003	12291508	2032-07-26	U-3018		2025-06-04
N212306-003	9079865	2032-07-26	U-2584		2021-07-19
N212306-003	9079865	2032-07-26	U-3018		2021-07-19
N212306-003	9714226	2032-07-26		Drug substance, Drug product	2021-07-19
N212306-003	8999996	2033-07-03		Drug substance, Drug product	2021-07-19
N212306-003	10519139	2035-08-14	U-2584	Drug substance, Drug product	2021-07-19
N212306-003	10519139	2035-08-14	U-3018	Drug substance, Drug product	2021-07-19
N212306-003	11746102	2035-08-14	U-2584		2023-10-04
N212306-003	11746102	2035-08-14	U-3018		2023-10-04
N212306-003	11753401	2035-08-14	U-2584	Drug product	2023-10-11
N212306-003	11753401	2035-08-14	U-3018	Drug product	2023-10-11
N212306-003	11807629	2035-08-14		Drug substance, Drug product	2023-12-06
N212306-004	10544108	2032-07-26	U-2584		2021-07-19
N212306-004	10544108	2032-07-26	U-3018		2021-07-19
N212306-004	11034660	2032-07-26	U-2584		2021-07-14
N212306-004	11034660	2032-07-26	U-3018		2021-07-14
N212306-004	11787771	2032-07-26	U-2584		2023-11-15
N212306-004	11787771	2032-07-26	U-3018		2023-11-15
N212306-004	12291508	2032-07-26	U-2584		2025-06-04
N212306-004	12291508	2032-07-26	U-3018		2025-06-04
N212306-004	9079865	2032-07-26	U-2584		2021-07-19
N212306-004	9079865	2032-07-26	U-3018		2021-07-19
N212306-004	9714226	2032-07-26		Drug substance, Drug product	2021-07-19
N212306-004	8999996	2033-07-03		Drug substance, Drug product	2021-07-19
N212306-004	10519139	2035-08-14	U-2584	Drug substance, Drug product	2021-07-19
N212306-004	10519139	2035-08-14	U-3018	Drug substance, Drug product	2021-07-19
N212306-004	11746102	2035-08-14	U-2584		2023-10-04
N212306-004	11746102	2035-08-14	U-3018		2023-10-04
N212306-004	11753401	2035-08-14	U-2584	Drug product	2023-10-11
N212306-004	11753401	2035-08-14	U-3018	Drug product	2023-10-11
N212306-004	11807629	2035-08-14		Drug substance, Drug product	2023-12-06
N212306-005	10544108	2032-07-26	U-2584		2025-04-08
N212306-005	10544108	2032-07-26	U-3018		2025-04-08
N212306-005	11034660	2032-07-26	U-2584		2025-04-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 17 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212306-001	ODE-257	2026-07-03
N212306-001	ODE-310	2027-06-22
N212306-001	ODE-346	2027-12-18
N212306-002	ODE*	2026-07-03
N212306-002	ODE*	2027-06-22
N212306-002	ODE*	2027-12-18
N212306-003	ODE*	2026-07-03
N212306-003	ODE*	2027-06-22
N212306-003	ODE*	2027-12-18
N212306-004	ODE*	2026-07-03
N212306-004	ODE*	2027-06-22
N212306-004	ODE*	2027-12-18
N212306-005	ODE*	2026-07-03
N212306-005	ODE*	2027-06-22
N212306-005	ODE*	2027-12-18
N212306-006	ODE*	2026-07-03
N212306-006	ODE*	2027-12-18

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 · 158 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-005	XPOVIO	10MG	TABLET / ORAL	RLD	2025-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-006	XPOVIO	80MG	TABLET / ORAL	RLD	2025-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-005	XPOVIO	10MG	TABLET / ORAL	RLD	2025-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-006	XPOVIO	80MG	TABLET / ORAL	RLD	2025-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-005	XPOVIO	10MG	TABLET / ORAL	RLD	2025-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-006	XPOVIO	80MG	TABLET / ORAL	RLD	2025-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-005	XPOVIO	10MG	TABLET / ORAL	RLD	2025-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212306-006	XPOVIO	80MG	TABLET / ORAL	RLD	2025-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212306-005	XPOVIO	10MG	TABLET / ORAL	RLD	2025-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212306-004	XPOVIO	60MG	TABLET / ORAL	RLD, RS	2021-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212306-001	XPOVIO	20MG	TABLET / ORAL	RLD	2019-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212306-002	XPOVIO	40MG	TABLET / ORAL	RLD	2021-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212306-003	XPOVIO	50MG	TABLET / ORAL	RLD	2021-04-15	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 71 · 2,801 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212306-001	10544108	2032-07-26	U-2584		2020-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	10544108	2032-07-26	U-3018		2020-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11034660	2032-07-26	U-2584		2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11034660	2032-07-26	U-3018		2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11787771	2032-07-26	U-2855		2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11787771	2032-07-26	U-2584		2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11787771	2032-07-26	U-3018		2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	12291508	2032-07-26	U-3018		2025-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	12291508	2032-07-26	U-2584		2025-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	9079865	2032-07-26	U-2584		2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	9079865	2032-07-26	U-3018		2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	9714226	2032-07-26		Drug substance, Drug product	2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	8999996	2033-07-03		Drug substance, Drug product	2019-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	10519139	2035-08-14	U-2584	Drug substance, Drug product	2020-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	10519139	2035-08-14	U-3018	Drug substance, Drug product	2020-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11746102	2035-08-14	U-2584		2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11746102	2035-08-14	U-3018		2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11753401	2035-08-14	U-2584	Drug product	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11753401	2035-08-14	U-3018	Drug product	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	11807629	2035-08-14		Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	10544108	2032-07-26	U-3018		2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	10544108	2032-07-26	U-2584		2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11034660	2032-07-26	U-2584		2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11034660	2032-07-26	U-3018		2021-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11787771	2032-07-26	U-3018		2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11787771	2032-07-26	U-2584		2023-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	12291508	2032-07-26	U-2584		2025-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	12291508	2032-07-26	U-3018		2025-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	9079865	2032-07-26	U-2584		2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	9079865	2032-07-26	U-3018		2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	9714226	2032-07-26		Drug substance, Drug product	2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	8999996	2033-07-03		Drug substance, Drug product	2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	10519139	2035-08-14	U-2584	Drug substance, Drug product	2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	10519139	2035-08-14	U-3018	Drug substance, Drug product	2021-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11746102	2035-08-14	U-2584		2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11746102	2035-08-14	U-3018		2023-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11753401	2035-08-14	U-2584	Drug product	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11753401	2035-08-14	U-3018	Drug product	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	11807629	2035-08-14		Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-003	10544108	2032-07-26	U-2584		2021-07-19	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 512 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N212306-001	ODE-257	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	ODE-310	2027-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-001	ODE-346	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	ODE*	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	ODE*	2027-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-002	ODE*	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-003	ODE*	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-003	ODE*	2027-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-003	ODE*	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-004	ODE*	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-004	ODE*	2027-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-004	ODE*	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-005	ODE*	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-005	ODE*	2027-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-005	ODE*	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-006	ODE*	2026-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212306-006	ODE*	2027-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212306-001	ODE-257	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-001	ODE-310	2027-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-001	ODE-346	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-002	ODE*	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-002	ODE*	2027-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-002	ODE*	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-003	ODE*	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-003	ODE*	2027-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-003	ODE*	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-004	ODE*	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-004	ODE*	2027-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-004	ODE*	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-005	ODE*	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-005	ODE*	2027-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-005	ODE*	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-006	ODE*	2026-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212306-006	ODE*	2027-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212306-001	ODE-257	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-001	ODE-310	2027-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-001	ODE-346	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-002	ODE*	2026-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-002	ODE*	2027-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212306-002	ODE*	2027-12-18	`011fe1cb6892…`

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
XPOVIO	SELINEXOR	Karyopharm Therapeutics Inc.	f6dd2682-75a6-4863-90a8-a3197f6f78a8	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212306 application number: NDA212306 ndc (product): 72237-101 ndc (product): 72237-104 ndc (product): 72237-103 ndc (product): 72237-102

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-101	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-102	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-102	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-102	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-102	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-103	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-103	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-103	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-103	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-104	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-104	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-104	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current
72237-104	XPOVIO	selinexor	Karyopharm Therapeutics Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85832	SUPPL	2026-05-05
85831	SUPPL	2026-05-05
85816	SUPPL	2026-05-04
83596	SUPPL	2025-09-30
83575	SUPPL	2025-09-26
81545	SUPPL	2025-03-12
81544	SUPPL	2025-03-12
71600	SUPPL	2022-07-19
71586	SUPPL	2022-07-18
70643	SUPPL	2022-03-29
70642	SUPPL	2022-03-29
70640	SUPPL	2022-03-29
65682	SUPPL	2020-12-22
65623	SUPPL	2020-12-18
65621	SUPPL	2020-12-18
63668	SUPPL	2020-06-23
63658	SUPPL	2020-06-22
63657	SUPPL	2020-06-22
59472	ORIG	2019-07-26
59247	ORIG	2019-07-05
59231	ORIG	2019-07-03
59230	ORIG	2019-07-03