Application 210861

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VITRAKVI	LAROTRECTINIB SULFATE	CAPSULE;ORAL	EQ 25MG BASE	Yes	No
002	VITRAKVI	LAROTRECTINIB SULFATE	CAPSULE;ORAL	EQ 100MG BASE	Yes	Yes

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

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
N210861-001	VITRAKVI	LAROTRECTINIB SULFATE	EQ 25MG BASE	CAPSULE / ORAL		RLD	2018-11-26
N210861-002	VITRAKVI	LAROTRECTINIB SULFATE	EQ 100MG BASE	CAPSULE / ORAL		RLD, RS	2018-11-26

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210861-001	10005783	2029-10-21	U-2472		2018-12-20
N210861-001	10047097	2029-10-21	U-2474		2018-12-20
N210861-001	10774085	2029-10-21	U-2470		2020-10-14
N210861-001	8865698	2029-10-21	U-2469		2018-12-20
N210861-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20
N210861-001	9447104	2029-10-21	U-2470		2018-12-20
N210861-001	9676783	2029-10-21	U-2469		2018-12-20
N210861-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20
N210861-001	10172861	2035-11-16		Drug substance, Drug product	2019-06-13
N210861-001	10285993	2035-11-16	U-2470		2019-06-13
N210861-001	10813936	2035-11-16	U-2987		2020-11-23
N210861-001	9782414	2035-11-16	U-2475		2018-12-20
N210861-001	10799505	2036-08-15		Drug substance, Drug product	2021-04-01
N210861-001	11337967	2037-05-16	U-4123		2025-02-19
N210861-001	11974998	2037-05-16	U-4124		2025-02-19
N210861-002	10005783	2029-10-21	U-2472		2018-12-20
N210861-002	10047097	2029-10-21	U-2474		2018-12-20
N210861-002	10774085	2029-10-21	U-2470		2020-10-14
N210861-002	8865698	2029-10-21	U-2469		2018-12-20
N210861-002	9127013	2029-10-21		Drug substance, Drug product	2018-12-20
N210861-002	9447104	2029-10-21	U-2470		2018-12-20
N210861-002	9676783	2029-10-21	U-2469		2018-12-20
N210861-002	8513263	2029-12-23		Drug substance, Drug product	2018-12-20
N210861-002	10172861	2035-11-16		Drug substance, Drug product	2019-06-13
N210861-002	10285993	2035-11-16	U-2470		2019-06-13
N210861-002	10813936	2035-11-16	U-2987		2020-11-23
N210861-002	9782414	2035-11-16	U-2475		2018-12-20
N210861-002	10799505	2036-08-15		Drug substance, Drug product	2021-04-01
N210861-002	11337967	2037-05-16	U-4123		2025-02-19
N210861-002	11974998	2037-05-16	U-4124		2025-02-19

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 · 82 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	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210861-001	VITRAKVI	EQ 25MG BASE	CAPSULE / ORAL	RLD	2018-11-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210861-002	VITRAKVI	EQ 100MG BASE	CAPSULE / ORAL	RLD, RS	2018-11-26	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,054 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	N210861-001	10005783	2029-10-21	U-2472		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10047097	2029-10-21	U-2474		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10774085	2029-10-21	U-2470		2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	8865698	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	9447104	2029-10-21	U-2470		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	9676783	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10172861	2035-11-16		Drug substance, Drug product	2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10285993	2035-11-16	U-2470		2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10813936	2035-11-16	U-2987		2020-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	9782414	2035-11-16	U-2475		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	10799505	2036-08-15		Drug substance, Drug product	2021-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	11337967	2037-05-16	U-4123		2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-001	11974998	2037-05-16	U-4124		2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10005783	2029-10-21	U-2472		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10047097	2029-10-21	U-2474		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10774085	2029-10-21	U-2470		2020-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	8865698	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	9127013	2029-10-21		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	9447104	2029-10-21	U-2470		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	9676783	2029-10-21	U-2469		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	8513263	2029-12-23		Drug substance, Drug product	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10172861	2035-11-16		Drug substance, Drug product	2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10285993	2035-11-16	U-2470		2019-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10813936	2035-11-16	U-2987		2020-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	9782414	2035-11-16	U-2475		2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	10799505	2036-08-15		Drug substance, Drug product	2021-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	11337967	2037-05-16	U-4123		2025-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210861-002	11974998	2037-05-16	U-4124		2025-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	10005783	2029-10-21	U-2472		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	10047097	2029-10-21	U-2474		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	10774085	2029-10-21	U-2470		2020-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	8865698	2029-10-21	U-2469		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	9127013	2029-10-21		Drug substance, Drug product	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	9447104	2029-10-21	U-2470		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	9676783	2029-10-21	U-2469		2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	8513263	2029-12-23		Drug substance, Drug product	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	10172861	2035-11-16		Drug substance, Drug product	2019-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	10285993	2035-11-16	U-2470		2019-06-13	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	ODE-215	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	ODE-220	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-001	ODE-221	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-002	ODE-215	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-002	ODE-220	2025-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210861-002	ODE-221	2025-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210861-001	ODE-215	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-001	ODE-220	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-001	ODE-221	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-002	ODE-215	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-002	ODE-220	2025-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210861-002	ODE-221	2025-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-001	ODE-215	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-001	ODE-220	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-001	ODE-221	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-002	ODE-215	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-002	ODE-220	2025-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210861-002	ODE-221	2025-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-001	ODE-215	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-001	ODE-220	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-001	ODE-221	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-002	ODE-215	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-002	ODE-220	2025-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210861-002	ODE-221	2025-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-001	ODE-215	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-001	ODE-220	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-001	ODE-221	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-002	ODE-215	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-002	ODE-220	2025-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210861-002	ODE-221	2025-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-001	ODE-215	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-001	ODE-220	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-001	ODE-221	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-002	ODE-215	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-002	ODE-220	2025-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210861-002	ODE-221	2025-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-001	ODE-215	2025-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-001	ODE-220	2025-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-001	ODE-221	2025-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210861-002	ODE-215	2025-11-26	`5bbf6a4d5a75…`

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
VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	0c8ca614-58b2-4aa4-83d3-0387a8f782fd	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210861 application number: NDA210861 ndc (product): 50419-391 ndc (product): 50419-390
VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	9525f887-a055-4e33-8e92-898d42828cd1	2018-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210861 application number: NDA210861 ndc (product): 71777-390 ndc (product): 71777-391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-390	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-391	VITRAKVI	LAROTRECTINIB	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
71777-390	VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	NDA	Current
71777-390	VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	NDA	Current
71777-391	VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	NDA	Current
71777-391	VITRAKVI	LAROTRECTINIB	Loxo Oncology, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82012	SUPPL	2025-04-25
81922	SUPPL	2025-04-10
76385	SUPPL	2023-11-06
76383	SUPPL	2023-11-06
72727	SUPPL	2022-11-28
72701	SUPPL	2022-11-25
66917	SUPPL	2021-03-30
66898	SUPPL	2021-03-29
66886	SUPPL	2021-03-26
56768	ORIG	2018-12-18
56701	ORIG	2018-12-11
56563	ORIG	2018-11-26