Application 216873

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	TABLET;ORAL	EQ 100MG BASE	Yes	No
002	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	No
003	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	TABLET;ORAL	EQ 200MG 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
N216873-001	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15
N216873-002	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15
N216873-003	OJJAARA	MOMELOTINIB DIHYDROCHLORIDE	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216873-001	8486941	2035-01-03	U-1201	Drug substance, Drug product	2023-10-04
N216873-001	9809559	2035-06-11	U-1201		2023-10-04
N216873-001	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04
N216873-001	12576089	2039-08-21	U-4441		2026-03-27
N216873-001	11963962	2040-12-02	U-3928		2024-05-21
N216873-002	8486941	2035-01-03	U-1201	Drug substance, Drug product	2023-10-04
N216873-002	9809559	2035-06-11	U-1201		2023-10-04
N216873-002	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04
N216873-002	12576089	2039-08-21	U-4441		2026-03-27
N216873-002	11963962	2040-12-02	U-3928		2024-05-21
N216873-003	8486941	2035-01-03	U-1201	Drug substance, Drug product	2023-10-04
N216873-003	9809559	2035-06-11	U-1201		2023-10-04
N216873-003	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04
N216873-003	12576089	2039-08-21	U-4441		2026-03-27
N216873-003	11963962	2040-12-02	U-3928		2024-05-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216873-001	NCE	2028-09-15
N216873-001	ODE-441	2030-09-15
N216873-002	NCE	2028-09-15
N216873-002	ODE-441	2030-09-15
N216873-003	NCE	2028-09-15
N216873-003	ODE-441	2030-09-15

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 · 60 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	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216873-002	OJJAARA	EQ 150MG BASE	TABLET / ORAL	RLD	2023-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216873-003	OJJAARA	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2023-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216873-001	OJJAARA	EQ 100MG BASE	TABLET / ORAL	RLD	2023-09-15	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 225 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	N216873-001	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-001	9809559	2035-06-11	U-1201		2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-001	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-001	11963962	2040-12-02	U-3928		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	9809559	2035-06-11	U-1201		2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	11963962	2040-12-02	U-3928		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	9809559	2035-06-11	U-1201		2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	11963962	2040-12-02	U-3928		2024-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	9809559	2035-06-11	U-1201		2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	11963962	2040-12-02	U-3928		2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	9809559	2035-06-11	U-1201		2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	11963962	2040-12-02	U-3928		2024-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	9809559	2035-06-11	U-1201		2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	11963962	2040-12-02	U-3928		2024-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216873-001	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-001	9809559	2035-06-11	U-1201		2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-001	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-001	11963962	2040-12-02	U-3928		2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	9809559	2035-06-11	U-1201		2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	11963962	2040-12-02	U-3928		2024-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	9809559	2035-06-11	U-1201		2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	11963962	2040-12-02	U-3928		2024-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	8486941	2030-01-03	U-1201	Drug substance, Drug product	2023-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	9809559	2035-06-11	U-1201		2023-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	RE48285	2035-06-11	U-1201	Drug substance, Drug product	2023-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	11963962	2040-12-02	U-3928		2024-05-21	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 120 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	N216873-001	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-001	ODE-441	2030-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-002	ODE-441	2030-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	NCE	2028-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216873-003	ODE-441	2030-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-001	ODE-441	2030-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-002	ODE-441	2030-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	NCE	2028-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216873-003	ODE-441	2030-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216873-001	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-001	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-002	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	NCE	2028-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216873-003	ODE-441	2030-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-001	ODE-441	2030-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-002	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-002	ODE-441	2030-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-003	NCE	2028-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216873-003	ODE-441	2030-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-001	NCE	2028-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-001	ODE-441	2030-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-002	NCE	2028-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-002	ODE-441	2030-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-003	NCE	2028-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216873-003	ODE-441	2030-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-001	NCE	2028-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-001	ODE-441	2030-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-002	NCE	2028-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-002	ODE-441	2030-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-003	NCE	2028-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216873-003	ODE-441	2030-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-001	NCE	2028-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-001	ODE-441	2030-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-002	NCE	2028-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216873-002	ODE-441	2030-09-15	`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
Ojjaara	MOMELOTINIB	GlaxoSmithKline LLC	4a672fd1-eb7b-4aa9-9b23-845e4b5dc400	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216873 application number: NDA216873

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85487	SUPPL	2026-03-24
85486	SUPPL	2026-03-24
85434	SUPPL	2026-03-20
85433	SUPPL	2026-03-20
82029	SUPPL	2025-04-28
82000	SUPPL	2025-04-25
75787	ORIG	2023-10-17
75502	ORIG	2023-09-18
75499	ORIG	2023-09-18