Application 218160

Type: NDA
Sponsor: ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETEVMO	SELPERCATINIB	TABLET;ORAL	40MG	Yes	No
002	RETEVMO	SELPERCATINIB	TABLET;ORAL	80MG	Yes	No
003	RETEVMO	SELPERCATINIB	TABLET;ORAL	120MG	Yes	No
004	RETEVMO	SELPERCATINIB	TABLET;ORAL	160MG	Yes	Yes
005	RETEVMO	SELPERCATINIB	CAPSULE;ORAL	40MG	No	No
006	RETEVMO	SELPERCATINIB	CAPSULE;ORAL	80MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218160-001	RETEVMO	SELPERCATINIB	40MG	TABLET / ORAL	RLD	2024-04-10
N218160-002	RETEVMO	SELPERCATINIB	80MG	TABLET / ORAL	RLD	2024-04-10
N218160-003	RETEVMO	SELPERCATINIB	120MG	TABLET / ORAL	RLD	2024-04-10
N218160-004	RETEVMO	SELPERCATINIB	160MG	TABLET / ORAL	RLD, RS	2024-04-10

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218160-001	10112942	2037-10-10		Drug substance, Drug product	2024-05-09
N218160-001	10137124	2037-10-10	U-3450		2024-05-09
N218160-001	10137124	2037-10-10	U-3949		2024-05-09
N218160-001	10137124	2037-10-10	U-3950		2024-05-09
N218160-001	10137124	2037-10-10	U-3951		2024-05-09
N218160-001	10172851	2037-10-10	U-3450		2024-05-09
N218160-001	10172851	2037-10-10	U-3949		2024-05-09
N218160-001	10172851	2037-10-10	U-3950		2024-05-09
N218160-001	10172851	2037-10-10	U-3951		2024-05-09
N218160-001	10112942*PED	2038-04-10		Pediatric extension
N218160-001	10137124*PED	2038-04-10		Pediatric extension
N218160-001	10172851*PED	2038-04-10		Pediatric extension
N218160-001	12138250	2038-10-10	U-3450		2024-12-05
N218160-001	12138250	2038-10-10	U-3949		2024-12-05
N218160-001	12138250	2038-10-10	U-3950		2024-12-05
N218160-001	12138250	2038-10-10	U-3951		2024-12-05
N218160-001	12138250*PED	2039-04-10		Pediatric extension
N218160-002	10112942	2037-10-10		Drug substance, Drug product	2024-05-09
N218160-002	10137124	2037-10-10	U-3450		2024-05-09
N218160-002	10137124	2037-10-10	U-3949		2024-05-09
N218160-002	10137124	2037-10-10	U-3950		2024-05-09
N218160-002	10137124	2037-10-10	U-3951		2024-05-09
N218160-002	10172851	2037-10-10	U-3450		2024-05-09
N218160-002	10172851	2037-10-10	U-3949		2024-05-09
N218160-002	10172851	2037-10-10	U-3950		2024-05-09
N218160-002	10172851	2037-10-10	U-3951		2024-05-09
N218160-002	10112942*PED	2038-04-10		Pediatric extension
N218160-002	10137124*PED	2038-04-10		Pediatric extension
N218160-002	10172851*PED	2038-04-10		Pediatric extension
N218160-002	12138250	2038-10-10	U-3450		2024-12-05
N218160-002	12138250	2038-10-10	U-3949		2024-12-05
N218160-002	12138250	2038-10-10	U-3950		2024-12-05
N218160-002	12138250	2038-10-10	U-3951		2024-12-05
N218160-002	12138250*PED	2039-04-10		Pediatric extension
N218160-003	10112942	2037-10-10		Drug substance, Drug product	2024-05-09
N218160-003	10137124	2037-10-10	U-3450		2024-05-09
N218160-003	10137124	2037-10-10	U-3949		2024-05-09
N218160-003	10137124	2037-10-10	U-3950		2024-05-09
N218160-003	10137124	2037-10-10	U-3951		2024-05-09
N218160-003	10172851	2037-10-10	U-3450		2024-05-09
N218160-003	10172851	2037-10-10	U-3949		2024-05-09
N218160-003	10172851	2037-10-10	U-3950		2024-05-09
N218160-003	10172851	2037-10-10	U-3951		2024-05-09
N218160-003	10112942*PED	2038-04-10		Pediatric extension
N218160-003	10137124*PED	2038-04-10		Pediatric extension
N218160-003	10172851*PED	2038-04-10		Pediatric extension
N218160-003	12138250	2038-10-10	U-3450		2024-12-05
N218160-003	12138250	2038-10-10	U-3949		2024-12-05
N218160-003	12138250	2038-10-10	U-3950		2024-12-05
N218160-003	12138250	2038-10-10	U-3951		2024-12-05
N218160-003	12138250*PED	2039-04-10		Pediatric extension
N218160-004	10112942	2037-10-10		Drug substance, Drug product	2024-05-09
N218160-004	10137124	2037-10-10	U-3450		2024-05-09
N218160-004	10137124	2037-10-10	U-3949		2024-05-09
N218160-004	10137124	2037-10-10	U-3950		2024-05-09
N218160-004	10137124	2037-10-10	U-3951		2024-05-09
N218160-004	10172851	2037-10-10	U-3450		2024-05-09
N218160-004	10172851	2037-10-10	U-3949		2024-05-09
N218160-004	10172851	2037-10-10	U-3950		2024-05-09
N218160-004	10172851	2037-10-10	U-3951		2024-05-09
N218160-004	10112942*PED	2038-04-10		Pediatric extension
N218160-004	10137124*PED	2038-04-10		Pediatric extension
N218160-004	10172851*PED	2038-04-10		Pediatric extension
N218160-004	12138250	2038-10-10	U-3450		2024-12-05
N218160-004	12138250	2038-10-10	U-3949		2024-12-05
N218160-004	12138250	2038-10-10	U-3950		2024-12-05
N218160-004	12138250	2038-10-10	U-3951		2024-12-05
N218160-004	12138250*PED	2039-04-10		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 80 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218160-001	ODE*	2027-05-08
N218160-001	ODE*	2027-05-08
N218160-001	ODE*	2027-05-08
N218160-001	M-311	2027-09-27
N218160-001	M-312	2027-09-27
N218160-001	PED	2027-11-08
N218160-001	PED	2027-11-08
N218160-001	PED	2027-11-08
N218160-001	PED	2028-03-27
N218160-001	PED	2028-03-27
N218160-001	ODE*	2029-09-21
N218160-001	ODE*	2029-09-21
N218160-001	PED	2030-03-21
N218160-001	PED	2030-03-21
N218160-001	ODE*	2031-05-29
N218160-001	ODE*	2031-05-29
N218160-001	ODE*	2031-05-29
N218160-001	PED	2031-11-29
N218160-001	PED	2031-11-29
N218160-001	PED	2031-11-29
N218160-002	ODE*	2027-05-08
N218160-002	ODE*	2027-05-08
N218160-002	ODE*	2027-05-08
N218160-002	M-311	2027-09-27
N218160-002	M-312	2027-09-27
N218160-002	PED	2027-11-08
N218160-002	PED	2027-11-08
N218160-002	PED	2027-11-08
N218160-002	PED	2028-03-27
N218160-002	PED	2028-03-27
N218160-002	ODE*	2029-09-21
N218160-002	ODE*	2029-09-21
N218160-002	PED	2030-03-21
N218160-002	PED	2030-03-21
N218160-002	ODE*	2031-05-29
N218160-002	ODE*	2031-05-29
N218160-002	ODE*	2031-05-29
N218160-002	PED	2031-11-29
N218160-002	PED	2031-11-29
N218160-002	PED	2031-11-29
N218160-003	ODE*	2027-05-08
N218160-003	ODE*	2027-05-08
N218160-003	ODE*	2027-05-08
N218160-003	M-311	2027-09-27
N218160-003	M-312	2027-09-27
N218160-003	PED	2027-11-08
N218160-003	PED	2027-11-08
N218160-003	PED	2027-11-08
N218160-003	PED	2028-03-27
N218160-003	PED	2028-03-27
N218160-003	ODE*	2029-09-21
N218160-003	ODE*	2029-09-21
N218160-003	PED	2030-03-21
N218160-003	PED	2030-03-21
N218160-003	ODE*	2031-05-29
N218160-003	ODE*	2031-05-29
N218160-003	ODE*	2031-05-29
N218160-003	PED	2031-11-29
N218160-003	PED	2031-11-29
N218160-003	PED	2031-11-29
N218160-004	ODE*	2027-05-08
N218160-004	ODE*	2027-05-08
N218160-004	ODE*	2027-05-08
N218160-004	M-311	2027-09-27
N218160-004	M-312	2027-09-27
N218160-004	PED	2027-11-08
N218160-004	PED	2027-11-08
N218160-004	PED	2027-11-08
N218160-004	PED	2028-03-27
N218160-004	PED	2028-03-27
N218160-004	ODE*	2029-09-21
N218160-004	ODE*	2029-09-21
N218160-004	PED	2030-03-21
N218160-004	PED	2030-03-21
N218160-004	ODE*	2031-05-29
N218160-004	ODE*	2031-05-29
N218160-004	ODE*	2031-05-29
N218160-004	PED	2031-11-29
N218160-004	PED	2031-11-29
N218160-004	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 · 68 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	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218160-001	RETEVMO	40MG	TABLET / ORAL	RLD	2024-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218160-002	RETEVMO	80MG	TABLET / ORAL	RLD	2024-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218160-003	RETEVMO	120MG	TABLET / ORAL	RLD	2024-04-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218160-004	RETEVMO	160MG	TABLET / ORAL	RLD, RS	2024-04-10	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 948 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	N218160-001	10112942	2037-10-10		Drug substance, Drug product	2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10137124	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10137124	2037-10-10	U-3949		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10137124	2037-10-10	U-3950		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10137124	2037-10-10	U-3951		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10172851	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10172851	2037-10-10	U-3949		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10172851	2037-10-10	U-3950		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10172851	2037-10-10	U-3951		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10112942*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10137124*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	10172851*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	12138250	2038-10-10	U-3450		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	12138250	2038-10-10	U-3949		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	12138250	2038-10-10	U-3951		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	12138250	2038-10-10	U-3950		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	12138250*PED	2039-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10112942	2037-10-10		Drug substance, Drug product	2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10137124	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10137124	2037-10-10	U-3949		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10137124	2037-10-10	U-3950		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10137124	2037-10-10	U-3951		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10172851	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10172851	2037-10-10	U-3949		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10172851	2037-10-10	U-3950		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10172851	2037-10-10	U-3951		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10112942*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10137124*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	10172851*PED	2038-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	12138250	2038-10-10	U-3450		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	12138250	2038-10-10	U-3951		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	12138250	2038-10-10	U-3950		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	12138250	2038-10-10	U-3949		2024-12-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	12138250*PED	2039-04-10		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10112942	2037-10-10		Drug substance, Drug product	2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10137124	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10137124	2037-10-10	U-3949		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10137124	2037-10-10	U-3950		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10137124	2037-10-10	U-3951		2024-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-003	10172851	2037-10-10	U-3450		2024-05-09	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 504 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	N218160-001	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	M-311	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	M-312	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-001	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2027-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	M-311	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	M-312	2027-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2027-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2028-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2029-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2030-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	ODE*	2031-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2031-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218160-002	PED	2031-11-29	`84e616aacf4f…`

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
84267	SUPPL	2025-11-21
84266	SUPPL	2025-11-21
84262	SUPPL	2025-11-21
84261	SUPPL	2025-11-21
81773	ORIG	2025-03-28
80646	SUPPL	2024-12-19
80639	SUPPL	2024-12-19
79767	SUPPL	2024-09-30
79766	SUPPL	2024-09-30
79760	SUPPL	2024-09-30
79759	SUPPL	2024-09-30
78786	SUPPL	2024-06-13
78778	SUPPL	2024-06-12
78113	ORIG	2024-04-12
78105	ORIG	2024-04-10