Application 217677

Type: NDA
Sponsor: SPRINGWORKS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OGSIVEO	NIROGACESTAT HYDROBROMIDE	TABLET;ORAL	EQ 50MG BASE	Yes	No
002	OGSIVEO	NIROGACESTAT HYDROBROMIDE	TABLET;ORAL	EQ 100MG BASE	Yes	No
003	OGSIVEO	NIROGACESTAT HYDROBROMIDE	TABLET;ORAL	EQ 150MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N217677-001	OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27
N217677-002	OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04
N217677-003	OGSIVEO	NIROGACESTAT HYDROBROMIDE	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04

Orange Book patents#

Current patent rows page 1 of 2 · 87 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217677-001	7795447	2030-08-18		Drug substance	2023-12-01
N217677-001	10590087	2039-08-09		Drug substance	2023-12-01
N217677-001	10710966	2039-08-09	U-3754	Drug substance	2023-12-01
N217677-001	10941118	2039-08-09	U-3754	Drug substance	2023-12-01
N217677-001	11820748	2039-08-09		Drug product	2023-12-01
N217677-001	11845732	2039-08-09	U-3754	Drug substance	2023-12-20
N217677-001	11884634	2039-08-09		Drug product	2024-01-31
N217677-001	11884635	2039-08-09		Drug product	2024-01-31
N217677-001	11905255	2039-08-09		Drug product	2024-02-21
N217677-001	12116347	2039-08-09		Drug product	2024-10-17
N217677-001	12297177	2039-08-09		Drug product	2025-05-19
N217677-001	11504354	2042-07-08		Drug product	2023-12-01
N217677-001	11612588	2042-07-08	U-3754	Drug product	2023-12-01
N217677-001	12110277	2042-07-08		Drug product	2024-10-17
N217677-001	12234210	2042-07-08		Drug product	2025-03-14
N217677-001	12247012	2042-07-08		Drug product	2025-03-14
N217677-001	12599587	2042-07-08		Drug product	2026-04-30
N217677-001	11807611	2042-09-08	U-3754	Drug product	2023-12-01
N217677-001	11844780	2042-09-08	U-3754	Drug product	2023-12-20
N217677-001	11872211	2043-05-19	U-3754		2024-01-17
N217677-001	11925619	2043-05-19	U-3754		2024-03-14
N217677-001	11925620	2043-05-19	U-3754		2024-03-14
N217677-001	11938116	2043-05-19	U-3754		2024-03-27
N217677-001	11951096	2043-05-19	U-3754		2024-04-24
N217677-001	11957662	2043-05-19	U-3754		2024-04-24
N217677-001	12011434	2043-05-19	U-3754		2024-06-24
N217677-001	12011435	2043-05-19	U-3754		2024-06-24
N217677-001	12036207	2043-05-19	U-3754		2024-07-25
N217677-001	12138246	2043-05-19	U-3754		2024-11-14
N217677-002	7795447	2030-08-18		Drug substance	2024-04-12
N217677-002	10590087	2039-08-09		Drug substance	2024-04-12
N217677-002	10710966	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-002	10941118	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-002	11820748	2039-08-09		Drug product	2024-04-12
N217677-002	11845732	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-002	11884634	2039-08-09		Drug product	2024-04-12
N217677-002	11884635	2039-08-09		Drug product	2024-04-12
N217677-002	11905255	2039-08-09		Drug product	2024-04-12
N217677-002	12116347	2039-08-09		Drug product	2024-10-17
N217677-002	12297177	2039-08-09		Drug product	2025-05-19
N217677-002	11504354	2042-07-08		Drug product	2024-04-12
N217677-002	11612588	2042-07-08	U-3754	Drug product	2024-04-12
N217677-002	12110277	2042-07-08		Drug product	2024-10-17
N217677-002	12234210	2042-07-08		Drug product	2025-03-14
N217677-002	12247012	2042-07-08		Drug product	2025-03-14
N217677-002	12599587	2042-07-08		Drug product	2026-04-30
N217677-002	11807611	2042-09-08	U-3754	Drug product	2024-04-12
N217677-002	11844780	2042-09-08	U-3754	Drug product	2024-04-12
N217677-002	11872211	2043-05-19	U-3754		2024-04-12
N217677-002	11925619	2043-05-19	U-3754		2024-04-12
N217677-002	11925620	2043-05-19	U-3754		2024-04-12
N217677-002	11938116	2043-05-19	U-3754		2024-04-12
N217677-002	11951096	2043-05-19	U-3754		2024-04-24
N217677-002	11957662	2043-05-19	U-3754		2024-04-24
N217677-002	12011434	2043-05-19	U-3754		2024-06-24
N217677-002	12011435	2043-05-19	U-3754		2024-06-24
N217677-002	12036207	2043-05-19	U-3754		2024-07-25
N217677-002	12138246	2043-05-19	U-3754		2024-11-14
N217677-003	7795447	2030-08-18		Drug substance	2024-04-12
N217677-003	10590087	2039-08-09		Drug substance	2024-04-12
N217677-003	10710966	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-003	10941118	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-003	11820748	2039-08-09		Drug product	2024-04-12
N217677-003	11845732	2039-08-09	U-3754	Drug substance	2024-04-12
N217677-003	11884634	2039-08-09		Drug product	2024-04-12
N217677-003	11884635	2039-08-09		Drug product	2024-04-12
N217677-003	11905255	2039-08-09		Drug product	2024-04-12
N217677-003	12116347	2039-08-09		Drug product	2024-10-17
N217677-003	12297177	2039-08-09		Drug product	2025-05-19
N217677-003	11504354	2042-07-08		Drug product	2024-04-12
N217677-003	11612588	2042-07-08	U-3754	Drug product	2024-04-12
N217677-003	12110277	2042-07-08		Drug product	2024-10-17
N217677-003	12234210	2042-07-08		Drug product	2025-03-14
N217677-003	12247012	2042-07-08		Drug product	2025-03-14
N217677-003	12599587	2042-07-08		Drug product	2026-04-30
N217677-003	11807611	2042-09-08	U-3754	Drug product	2024-04-12
N217677-003	11844780	2042-09-08	U-3754	Drug product	2024-04-12
N217677-003	11872211	2043-05-19	U-3754		2024-04-12
N217677-003	11925619	2043-05-19	U-3754		2024-04-12
N217677-003	11925620	2043-05-19	U-3754		2024-04-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217677-001	NCE	2028-11-27
N217677-001	ODE-452	2030-11-27
N217677-002	NCE	2028-11-27
N217677-002	ODE*	2030-11-27
N217677-003	NCE	2028-11-27
N217677-003	ODE*	2030-11-27

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 · 48 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	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217677-002	OGSIVEO	EQ 100MG BASE	TABLET / ORAL	RLD	2024-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217677-003	OGSIVEO	EQ 150MG BASE	TABLET / ORAL	RLD, RS	2024-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217677-001	OGSIVEO	EQ 50MG BASE	TABLET / ORAL	RLD	2023-11-27	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,205 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	N217677-001	7795447	2030-08-18		Drug substance	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	10590087	2039-08-09		Drug substance	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	10710966	2039-08-09	U-3754	Drug substance	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	10941118	2039-08-09	U-3754	Drug substance	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11820748	2039-08-09		Drug product	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11845732	2039-08-09	U-3754	Drug substance	2023-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11884634	2039-08-09		Drug product	2024-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11884635	2039-08-09		Drug product	2024-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11905255	2039-08-09		Drug product	2024-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12116347	2039-08-09		Drug product	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12297177	2039-08-09		Drug product	2025-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11504354	2042-07-08		Drug product	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11612588	2042-07-08	U-3754	Drug product	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12110277	2042-07-08		Drug product	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12234210	2042-07-08		Drug product	2025-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12247012	2042-07-08		Drug product	2025-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11807611	2042-09-08	U-3754	Drug product	2023-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11844780	2042-09-08	U-3754	Drug product	2023-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11872211	2043-05-19	U-3754		2024-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11925619	2043-05-19	U-3754		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11925620	2043-05-19	U-3754		2024-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11938116	2043-05-19	U-3754		2024-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11951096	2043-05-19	U-3754		2024-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	11957662	2043-05-19	U-3754		2024-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12011434	2043-05-19	U-3754		2024-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12011435	2043-05-19	U-3754		2024-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12036207	2043-05-19	U-3754		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	12138246	2043-05-19	U-3754		2024-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	7795447	2030-08-18		Drug substance	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	10590087	2039-08-09		Drug substance	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	10710966	2039-08-09	U-3754	Drug substance	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	10941118	2039-08-09	U-3754	Drug substance	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11820748	2039-08-09		Drug product	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11845732	2039-08-09	U-3754	Drug substance	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11884634	2039-08-09		Drug product	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11884635	2039-08-09		Drug product	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11905255	2039-08-09		Drug product	2024-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	12116347	2039-08-09		Drug product	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	12297177	2039-08-09		Drug product	2025-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	11504354	2042-07-08		Drug product	2024-04-12	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 94 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	N217677-001	NCE	2028-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-001	ODE-452	2030-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	NCE	2028-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-002	ODE*	2030-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-003	NCE	2028-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217677-003	ODE*	2030-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-001	NCE	2028-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-001	ODE-452	2030-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-002	NCE	2028-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-002	ODE*	2030-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-003	NCE	2028-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217677-003	ODE*	2030-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217677-001	NCE	2028-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-001	ODE-452	2030-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-002	NCE	2028-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-002	ODE*	2030-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-003	NCE	2028-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217677-003	ODE*	2030-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-001	NCE	2028-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-001	ODE-452	2030-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-002	NCE	2028-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-002	ODE*	2030-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-003	NCE	2028-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217677-003	ODE*	2030-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-001	NCE	2028-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-001	ODE-452	2030-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-002	NCE	2028-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-002	ODE*	2030-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-003	NCE	2028-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217677-003	ODE*	2030-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-001	NCE	2028-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-001	ODE-452	2030-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-002	NCE	2028-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-002	ODE*	2030-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-003	NCE	2028-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217677-003	ODE*	2030-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-001	NCE	2028-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-001	ODE-452	2030-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-002	NCE	2028-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217677-002	ODE*	2030-11-27	`2680178bc6a6…`

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
OGSIVEO	NIROGACESTAT	SpringWorks Therapeutics, Inc.	f172e6ff-3190-41b0-b95a-58a7ef9e9e1e	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217677 application number: NDA217677

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85361	SUPPL	2026-03-12
85342	SUPPL	2026-03-12
78249	SUPPL	2024-04-25
78248	SUPPL	2024-04-25
77150	ORIG	2023-12-27
76669	ORIG	2023-12-27
76667	ORIG	2023-12-15