Application 217900

Type: NDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEQSELVI	DEURUXOLITINIB PHOSPHATE	TABLET;ORAL	EQ 8MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217900-001	LEQSELVI	DEURUXOLITINIB PHOSPHATE	EQ 8MG BASE	TABLET / ORAL		RLD, RS	2024-07-25

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217900-001	10561659	2037-05-04	U-3976		2024-08-23
N217900-001	12076323	2037-05-04	U-3976		2024-10-01
N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23
N217900-001	12285432	2042-08-11	U-3976		2025-05-29
N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08
N217900-001	12364699	2044-10-10	U-3976		2025-08-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217900-001	NCE	2029-07-25

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.

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	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 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	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217900-001	NCE	2029-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217900-001	NCE	2029-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217900-001	NCE	2029-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217900-001	NCE	2029-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217900-001	NCE	2029-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217900-001	NCE	2029-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217900-001	NCE	2029-07-25	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217900-001	NCE	2029-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217900-001	NCE	2029-07-25	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217900-001	NCE	2029-07-25	`a50c72e98297…`

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
LEQSELVI	DEURUXOLITINIB PHOSPHATE	Sun Pharmaceutical Industries, Inc.	a603f231-d09e-4bad-ad5e-b55f865da095	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217900 application number: NDA217900

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79464	ORIG	2024-08-23
79317	ORIG	2024-08-06
79240	ORIG	2024-08-06
79242	ORIG	2024-07-29