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 44.

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
2026-10-15 13:18:30	2026-09	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	LEQSELVI	EQ 8MG BASE	TABLET / ORAL	RLD, RS	2024-07-25	`caaa826d4ba7…`
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 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	10561659	2037-05-04	U-3976		2024-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12076323	2037-05-04	U-3976		2024-10-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	11919907	2041-05-21	U-3976	Drug product	2024-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12285432	2042-08-11	U-3976		2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12247034	2044-05-10		Drug substance, Drug product	2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217900-001	12364699	2044-10-10	U-3976		2025-08-21	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N217900-001	NCE	2029-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217900-001	NCE	2029-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217900-001	NCE	2029-07-25	`caaa826d4ba7…`
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…`

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
79464	ORIG	2024-08-23
79317	ORIG	2024-08-06
79240	ORIG	2024-08-06
79242	ORIG	2024-07-29