Application 022287

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXILANT	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	30MG	Yes	No
002	DEXILANT	DEXLANSOPRAZOLE	CAPSULE, DELAYED RELEASE;ORAL	60MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022287-001	DEXILANT	DEXLANSOPRAZOLE	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30
N022287-002	DEXILANT	DEXLANSOPRAZOLE	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022287-001	AB
N022287-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022287-001	8461187	2026-01-17		Drug product
N022287-001	9238029	2026-01-17		Drug product	2016-02-11
N022287-001	9011926	2026-02-24		Drug product	2015-05-01
N022287-001	8461187*PED	2026-07-17		Pediatric extension
N022287-001	7790755	2026-08-02		Drug product	2010-09-29
N022287-001	8105626	2026-09-27		Drug product	2012-02-28
N022287-001	7790755*PED	2027-02-02		Pediatric extension
N022287-001	8105626*PED	2027-03-27		Pediatric extension
N022287-001	8871273	2028-01-11		Drug product	2014-12-01
N022287-001	8173158	2030-03-17	U-949		2012-06-01
N022287-001	8173158	2030-03-17	U-950		2012-06-01
N022287-001	8173158	2030-03-17	U-951		2012-06-01
N022287-001	8173158*PED	2030-09-17		Pediatric extension
N022287-001	9233103	2032-03-05	U-1805		2016-02-11
N022287-002	8461187	2026-01-17		Drug product
N022287-002	9238029	2026-01-17		Drug product	2016-02-11
N022287-002	9011926	2026-02-24		Drug product	2015-05-01
N022287-002	8461187*PED	2026-07-17		Pediatric extension
N022287-002	7790755	2026-08-02		Drug product
N022287-002	8105626	2026-09-27		Drug product
N022287-002	7790755*PED	2027-02-02		Pediatric extension
N022287-002	8105626*PED	2027-03-27		Pediatric extension
N022287-002	8871273	2028-01-11		Drug product	2014-12-01
N022287-002	8173158	2030-03-17	U-949
N022287-002	8173158	2030-03-17	U-950
N022287-002	8173158	2030-03-17	U-951
N022287-002	8173158*PED	2030-09-17		Pediatric extension
N022287-002	9233103	2032-03-05	U-1805		2016-02-11

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2009-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022287-001	DEXILANT	30MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2009-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	DEXILANT	60MG	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2009-01-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022287-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022287-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022287-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022287-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022287-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022287-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022287-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022287-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022287-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022287-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022287-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022287-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022287-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022287-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022287-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022287-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022287-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022287-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022287-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022287-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022287-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022287-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022287-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022287-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022287-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022287-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022287-002	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,908 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022287-001	8461187	2026-01-17		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9238029	2026-01-17		Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9011926	2026-02-24		Drug product	2015-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8461187*PED	2026-07-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	7790755	2026-08-02		Drug product	2010-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8105626	2026-09-27		Drug product	2012-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	7790755*PED	2027-02-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8105626*PED	2027-03-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8871273	2028-01-11		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-951		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-949		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158	2030-03-17	U-950		2012-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	8173158*PED	2030-09-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-001	9233103	2032-03-05	U-1805		2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8461187	2026-01-17		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9238029	2026-01-17		Drug product	2016-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9011926	2026-02-24		Drug product	2015-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8461187*PED	2026-07-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	7790755	2026-08-02		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8105626	2026-09-27		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	7790755*PED	2027-02-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8105626*PED	2027-03-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8871273	2028-01-11		Drug product	2014-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-951			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-950			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158	2030-03-17	U-949			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	8173158*PED	2030-09-17		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022287-002	9233103	2032-03-05	U-1805		2016-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022287-001	8461187	2026-01-17		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	9238029	2026-01-17		Drug product	2016-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	9011926	2026-02-24		Drug product	2015-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8461187*PED	2026-07-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	7790755	2026-08-02		Drug product	2010-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8105626	2026-09-27		Drug product	2012-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	7790755*PED	2027-02-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8105626*PED	2027-03-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8871273	2028-01-11		Drug product	2014-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-951		2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-949		2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022287-001	8173158	2030-03-17	U-950		2012-06-01	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-001	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022287-002	NPP	2019-07-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-001	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022287-002	NPP	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-001	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022287-002	NPP	2019-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-001	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022287-002	NPP	2019-07-08	`ea99ee380514…`

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
Dexilant	DEXLANSOPRAZOLE	Takeda Pharmaceuticals America, Inc.	9819f033-3bbe-442e-8e92-45fec77b237d	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022287 application number: NDA022287 ndc (product): 64764-175 ndc (product): 64764-171
Dexlansoprazole delayed release	DEXLANSOPRAZOLE	A-S Medication Solutions	7c7698da-3cda-4301-ae93-02fb64b9c90d	2023-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022287 application number: NDA022287 ndc (product): 50090-5944

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24979-703	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	NDA AUTHORIZED GENERIC	Current
24979-703	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	NDA AUTHORIZED GENERIC	Current
24979-704	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	NDA AUTHORIZED GENERIC	Current
24979-704	Dexlansoprazole	dexlansoprazole	TWI PHARMACEUTICALS, INC.	NDA AUTHORIZED GENERIC	Current
50090-4374	Dexilant	dexlansoprazole	A-S Medication Solutions	NDA	Current
50090-4374	Dexilant	dexlansoprazole	A-S Medication Solutions	NDA	Current
50090-4374	Dexilant	dexlansoprazole	A-S Medication Solutions	NDA	Current
50090-5944	Dexlansoprazole	dexlansoprazole	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5956	Dexlansoprazole	dexlansoprazole	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
55154-5154	Dexilant	dexlansoprazole	Cardinal Health	NDA	Current
55154-5154	Dexilant	dexlansoprazole	Cardinal Health 107, LLC	NDA	Current
55154-5154	Dexilant	dexlansoprazole	Cardinal Health	NDA	Current
55154-5154	Dexilant	dexlansoprazole	Cardinal Health	NDA	Current
55154-5154	Dexilant	dexlansoprazole	Cardinal Health	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-171	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-175	Dexilant	dexlansoprazole	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74822	SUPPL	2023-07-20
74821	SUPPL	2023-07-20
74781	SUPPL	2023-07-19
73999	SUPPL	2023-04-14
73987	SUPPL	2023-04-14
70475	SUPPL	2022-03-10
70473	SUPPL	2022-03-10
70428	SUPPL	2022-03-07
65398	SUPPL	2020-11-30
65397	SUPPL	2020-11-30
65387	SUPPL	2020-11-30
64620	SUPPL	2020-09-21
64616	SUPPL	2020-09-21
54579	SUPPL	2018-06-14
54578	SUPPL	2018-06-14
54510	SUPPL	2018-06-11
54509	SUPPL	2018-06-11
54508	SUPPL	2018-06-11
54507	SUPPL	2018-06-11
50149	SUPPL	2017-10-23
50117	SUPPL	2017-10-19
45871	SUPPL	2016-11-10
45866	SUPPL	2016-11-10
38515	SUPPL	2016-07-20
38514	SUPPL	2016-07-20
17204	SUPPL	2016-07-20
29540	SUPPL	2016-07-12
29539	SUPPL	2016-07-12
7181	SUPPL	2016-07-12
38513	SUPPL	2016-02-11
29538	SUPPL	2016-02-04
7180	SUPPL	2015-12-18
38511	SUPPL	2015-12-17
38512	SUPPL	2014-12-29
29537	SUPPL	2014-12-23
29536	SUPPL	2013-08-22
38510	SUPPL	2013-08-21
29534	SUPPL	2012-10-02
38508	SUPPL	2012-10-01
29535	SUPPL	2012-05-09
38509	SUPPL	2012-05-07
23707	ORIG	2011-12-20
17202	SUPPL	2011-11-01
7179	SUPPL	2011-10-31
29532	SUPPL	2011-06-28
38507	SUPPL	2011-06-27
17203	SUPPL	2011-05-26
29533	SUPPL	2011-05-25
38506	SUPPL	2011-04-11
29531	SUPPL	2011-04-11
38505	SUPPL	2010-09-10
29530	SUPPL	2010-09-08
29528	SUPPL	2010-06-24
17199	SUPPL	2010-06-24
17201	SUPPL	2010-03-26
17200	SUPPL	2010-03-26
29529	SUPPL	2010-03-25
7178	SUPPL	2010-03-25
42479	ORIG	2009-06-24
24275	ORIG	2009-06-24
7177	ORIG	2009-02-04