Application 213246

Type: NDA
Sponsor: LOXO ONCOLOGY INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETEVMO	SELPERCATINIB	CAPSULE;ORAL	40MG	Yes	No
002	RETEVMO	SELPERCATINIB	CAPSULE;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213246-001	RETEVMO	SELPERCATINIB	40MG	CAPSULE / ORAL		RLD	2020-05-08
N213246-002	RETEVMO	SELPERCATINIB	80MG	CAPSULE / ORAL		RLD, RS	2020-05-08

Orange Book patents#

Current patent rows page 1 of 1 · 54 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213246-001	10112942	2037-10-10		Drug substance, Drug product	2020-06-05
N213246-001	10137124	2037-10-10	U-3450		2020-06-05
N213246-001	10137124	2037-10-10	U-3949		2020-06-05
N213246-001	10137124	2037-10-10	U-3950		2020-06-05
N213246-001	10137124	2037-10-10	U-3951		2020-06-05
N213246-001	10172851	2037-10-10	U-3450		2020-06-05
N213246-001	10172851	2037-10-10	U-3949		2020-06-05
N213246-001	10172851	2037-10-10	U-3950		2020-06-05
N213246-001	10172851	2037-10-10	U-3951		2020-06-05
N213246-001	10112942*PED	2038-04-10		Pediatric extension
N213246-001	10137124*PED	2038-04-10		Pediatric extension
N213246-001	10172851*PED	2038-04-10		Pediatric extension
N213246-001	10584124	2038-10-10	U-3450	Drug substance	2020-06-05
N213246-001	10584124	2038-10-10	U-3949	Drug substance	2020-06-05
N213246-001	10584124	2038-10-10	U-3950	Drug substance	2020-06-05
N213246-001	10584124	2038-10-10	U-3951	Drug substance	2020-06-05
N213246-001	10786489	2038-10-10	U-3450	Drug product	2020-10-26
N213246-001	10786489	2038-10-10	U-3949	Drug product	2020-10-26
N213246-001	10786489	2038-10-10	U-3950	Drug product	2020-10-26
N213246-001	10786489	2038-10-10	U-3951	Drug product	2020-10-26
N213246-001	12138250	2038-10-10	U-3450		2024-12-05
N213246-001	12138250	2038-10-10	U-3949		2024-12-05
N213246-001	12138250	2038-10-10	U-3950		2024-12-05
N213246-001	12138250	2038-10-10	U-3951		2024-12-05
N213246-001	10584124*PED	2039-04-10		Pediatric extension
N213246-001	10786489*PED	2039-04-10		Pediatric extension
N213246-001	12138250*PED	2039-04-10		Pediatric extension
N213246-002	10112942	2037-10-10		Drug substance, Drug product	2020-06-05
N213246-002	10137124	2037-10-10	U-3450		2020-06-05
N213246-002	10137124	2037-10-10	U-3949		2020-06-05
N213246-002	10137124	2037-10-10	U-3950		2020-06-05
N213246-002	10137124	2037-10-10	U-3951		2020-06-05
N213246-002	10172851	2037-10-10	U-3450		2020-06-05
N213246-002	10172851	2037-10-10	U-3949		2020-06-05
N213246-002	10172851	2037-10-10	U-3950		2020-06-05
N213246-002	10172851	2037-10-10	U-3951		2020-06-05
N213246-002	10112942*PED	2038-04-10		Pediatric extension
N213246-002	10137124*PED	2038-04-10		Pediatric extension
N213246-002	10172851*PED	2038-04-10		Pediatric extension
N213246-002	10584124	2038-10-10	U-3450	Drug substance	2020-06-05
N213246-002	10584124	2038-10-10	U-3949	Drug substance	2020-06-05
N213246-002	10584124	2038-10-10	U-3950	Drug substance	2020-06-05
N213246-002	10584124	2038-10-10	U-3951	Drug substance	2020-06-05
N213246-002	10786489	2038-10-10	U-3450	Drug product	2020-10-26
N213246-002	10786489	2038-10-10	U-3949	Drug product	2020-10-26
N213246-002	10786489	2038-10-10	U-3950	Drug product	2020-10-26
N213246-002	10786489	2038-10-10	U-3951	Drug product	2020-10-26
N213246-002	12138250	2038-10-10	U-3450		2024-12-05
N213246-002	12138250	2038-10-10	U-3949		2024-12-05
N213246-002	12138250	2038-10-10	U-3950		2024-12-05
N213246-002	12138250	2038-10-10	U-3951		2024-12-05
N213246-002	10584124*PED	2039-04-10		Pediatric extension
N213246-002	10786489*PED	2039-04-10		Pediatric extension
N213246-002	12138250*PED	2039-04-10		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 44 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213246-001	ODE-301	2027-05-08
N213246-001	ODE-302	2027-05-08
N213246-001	ODE-303	2027-05-08
N213246-001	NPP	2027-05-29
N213246-001	M-311	2027-09-27
N213246-001	M-312	2027-09-27
N213246-001	PED	2027-11-08
N213246-001	PED	2027-11-08
N213246-001	PED	2027-11-08
N213246-001	PED	2027-11-29
N213246-001	PED	2028-03-27
N213246-001	PED	2028-03-27
N213246-001	ODE-409	2029-09-21
N213246-001	ODE-412	2029-09-21
N213246-001	PED	2030-03-21
N213246-001	PED	2030-03-21
N213246-001	ODE-484	2031-05-29
N213246-001	ODE-485	2031-05-29
N213246-001	ODE-487	2031-05-29
N213246-001	PED	2031-11-29
N213246-001	PED	2031-11-29
N213246-001	PED	2031-11-29
N213246-002	ODE-301	2027-05-08
N213246-002	ODE-302	2027-05-08
N213246-002	ODE-303	2027-05-08
N213246-002	NPP	2027-05-29
N213246-002	M-311	2027-09-27
N213246-002	M-312	2027-09-27
N213246-002	PED	2027-11-08
N213246-002	PED	2027-11-08
N213246-002	PED	2027-11-08
N213246-002	PED	2027-11-29
N213246-002	PED	2028-03-27
N213246-002	PED	2028-03-27
N213246-002	ODE-409	2029-09-21
N213246-002	ODE-412	2029-09-21
N213246-002	PED	2030-03-21
N213246-002	PED	2030-03-21
N213246-002	ODE-484	2031-05-29
N213246-002	ODE-485	2031-05-29
N213246-002	ODE-487	2031-05-29
N213246-002	PED	2031-11-29
N213246-002	PED	2031-11-29
N213246-002	PED	2031-11-29

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 · 78 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	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213246-001	RETEVMO	40MG	CAPSULE / ORAL	RLD	2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213246-002	RETEVMO	80MG	CAPSULE / ORAL	RLD, RS	2020-05-08	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 51 · 2,002 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	N213246-001	10112942	2037-10-10		Drug substance, Drug product	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10137124	2037-10-10	U-3450		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10137124	2037-10-10	U-3949		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10137124	2037-10-10	U-3950		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10137124	2037-10-10	U-3951		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10172851	2037-10-10	U-3450		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10172851	2037-10-10	U-3949		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10172851	2037-10-10	U-3950		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10172851	2037-10-10	U-3951		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10112942*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10137124*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10172851*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10584124	2038-10-10	U-3450	Drug substance	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10584124	2038-10-10	U-3949	Drug substance	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10584124	2038-10-10	U-3950	Drug substance	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10584124	2038-10-10	U-3951	Drug substance	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10786489	2038-10-10	U-3450	Drug product	2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10786489	2038-10-10	U-3949	Drug product	2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10786489	2038-10-10	U-3951	Drug product	2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10786489	2038-10-10	U-3950	Drug product	2020-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	12138250	2038-10-10	U-3949		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	12138250	2038-10-10	U-3951		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	12138250	2038-10-10	U-3950		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	12138250	2038-10-10	U-3450		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10584124*PED	2039-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	10786489*PED	2039-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	12138250*PED	2039-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10112942	2037-10-10		Drug substance, Drug product	2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10137124	2037-10-10	U-3450		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10137124	2037-10-10	U-3949		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10137124	2037-10-10	U-3951		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10137124	2037-10-10	U-3950		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10172851	2037-10-10	U-3951		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10172851	2037-10-10	U-3949		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10172851	2037-10-10	U-3950		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10172851	2037-10-10	U-3450		2020-06-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10112942*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10137124*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10172851*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	10584124	2038-10-10	U-3450	Drug substance	2020-06-05	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 664 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	N213246-001	ODE-301	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-302	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-303	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	NPP	2027-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	M-311	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	M-312	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2027-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-409	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-412	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-484	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-485	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	ODE-487	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-301	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-302	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-303	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	NPP	2027-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	M-311	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	M-312	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2027-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-409	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-412	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-484	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213246-002	ODE-485	2031-05-29	`84e616aacf4f…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85560	SUPPL	2026-03-30
85559	SUPPL	2026-03-30
84265	SUPPL	2025-11-21
84264	SUPPL	2025-11-21
84260	SUPPL	2025-11-21
84258	SUPPL	2025-11-21
80642	SUPPL	2024-12-19
80640	SUPPL	2024-12-19
79779	SUPPL	2024-09-30
79778	SUPPL	2024-09-30
79765	SUPPL	2024-09-30
79764	SUPPL	2024-09-30
78787	SUPPL	2024-06-13
78783	SUPPL	2024-06-13
78581	SUPPL	2024-05-30
78568	SUPPL	2024-05-29
78111	SUPPL	2024-04-12
78108	SUPPL	2024-04-11
72177	SUPPL	2022-09-28
72176	SUPPL	2022-09-28
72137	SUPPL	2022-09-22
72136	SUPPL	2022-09-22
66043	SUPPL	2021-02-01
66028	SUPPL	2021-02-01
64233	ORIG	2020-08-07
62897	ORIG	2020-05-11
62880	ORIG	2020-05-08