Application 021957

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 20MG BASE/PACKET	Yes	No
002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 40MG BASE/PACKET	Yes	Yes
003	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 2.5MG BASE/PACKET	Yes	No
004	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 5MG BASE/PACKET	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021957-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20
N021957-002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20
N021957-003	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15
N021957-004	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021957-001	AB
N021957-002	AB
N021957-003	AB
N021957-004	AB

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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2011-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021957-001	NEXIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-002	NEXIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-003	NEXIUM	EQ 2.5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-004	NEXIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD	2011-12-15	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021957-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021957-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021957-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021957-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021957-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021957-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021957-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021957-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021957-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021957-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021957-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021957-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021957-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021957-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021957-002	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810	2019-11-03	U-773	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810	2019-11-03	U-729	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-729	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810	2019-11-03	U-773	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-003	6428810	2019-11-03	U-1207	Drug product	2012-01-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-004	6428810	2019-11-03	U-1207	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-773	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810	2019-11-03	U-729	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-729	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810	2019-11-03	U-773	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-003	6428810	2019-11-03	U-1207	Drug product	2012-01-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-003	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-004	6428810	2019-11-03	U-1207	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021957-004	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-1207	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-773	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810	2019-11-03	U-729	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-001	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-1207	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-729	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810	2019-11-03	U-773	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021957-002	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`

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
NEXIUM	ESOMEPRAZOLE MAGNESIUM	AstraZeneca Pharmaceuticals LP	f4853677-1622-4037-688b-fdf533a11d96	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021957 application number: NDA021957 ndc (product): 0186-4025 ndc (product): 0186-4020 ndc (product): 0186-4040 ndc (product): 0186-4050

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
61919-509	NEXIUM	esomeprazole magnesium	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74836	SUPPL	2023-07-20
74835	SUPPL	2023-07-20
74799	SUPPL	2023-07-19
74774	SUPPL	2022-03-10
70458	SUPPL	2022-03-10
70457	SUPPL	2022-03-10
70412	SUPPL	2022-03-07
68489	SUPPL	2021-08-31
68488	SUPPL	2021-08-31
68478	SUPPL	2021-08-27
65409	SUPPL	2020-11-30
65408	SUPPL	2020-11-30
65380	SUPPL	2020-11-30
54566	SUPPL	2018-06-14
54501	SUPPL	2018-06-11
54500	SUPPL	2018-06-11
46479	SUPPL	2016-12-22
46487	SUPPL	2016-12-21
45695	SUPPL	2016-10-28
45662	SUPPL	2016-10-26
37956	SUPPL	2014-12-29
28924	SUPPL	2014-12-24
16641	SUPPL	2014-04-01
28923	SUPPL	2014-03-28
16642	SUPPL	2014-03-05
6544	SUPPL	2014-02-27
37955	SUPPL	2012-12-10
28922	SUPPL	2012-11-29
37953	SUPPL	2012-10-12
6542	SUPPL	2012-10-11
6543	SUPPL	2012-10-02
37954	SUPPL	2012-10-01
28921	SUPPL	2012-01-24
16640	SUPPL	2012-01-24
28916	SUPPL	2011-12-28
37949	SUPPL	2011-12-23
44161	ORIG	2011-12-20
28920	SUPPL	2011-07-06
16639	SUPPL	2011-07-06
37952	SUPPL	2011-06-29
6541	SUPPL	2011-06-27
28917	SUPPL	2010-09-23
16638	SUPPL	2010-09-10
28919	SUPPL	2010-09-09
28918	SUPPL	2010-03-08
37951	SUPPL	2010-03-05
37950	SUPPL	2009-06-24
6540	SUPPL	2009-01-21
16637	SUPPL	2009-01-16
21885	ORIG	2008-09-05
28915	SUPPL	2008-01-18
37948	ORIG	2007-03-27
28914	ORIG	2006-10-26
53265	SUPPL	1900-01-01
53264	SUPPL	1900-01-01