Application 021153

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	Yes	No
002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 40MG 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021153-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20
N021153-002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021153-001	AB
N021153-002	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 3 · 82 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	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	NEXIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD	2001-02-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	NEXIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	RLD, RS	2001-02-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021153-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021153-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021153-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021153-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021153-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021153-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021153-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021153-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021153-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021153-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021153-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021153-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021153-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021153-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021153-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021153-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021153-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021153-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021153-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021153-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021153-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021153-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021153-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021153-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021153-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021153-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021153-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6147103*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6166213*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6191148*PED	2019-04-09		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-770	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-729	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810	2019-11-03	U-469	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021153-002	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6147103*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6166213*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6191148*PED	2019-04-09		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-729	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-770	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810	2019-11-03	U-469	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-001	6428810*PED	2020-05-03		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021153-002	6147103*PED	2019-04-09		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): 021153 application number: NDA021153 ndc (product): 0186-5020 ndc (product): 0186-5040

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA AUTHORIZED	Current
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA AUTHORIZED	Current
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
21695-091	NEXIUM	Esomeprazole magnesium	Rebel Distributors Corp	NDA	Current
21695-092	NEXIUM	Esomeprazole magnesium	Rebel Distributors Corp	NDA	Current
49999-307	NEXIUM	Esomeprazole magnesium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-0742	NEXIUM	Esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-0742	NEXIUM	Esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-4639	Esomeprazole magnesium	Esomeprazole magnesium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-4639	Esomeprazole magnesium	Esomeprazole magnesium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50436-3121	NEXIUM	Esomeprazole magnesium	Unit Dose Services	NDA	Current
55154-9616	NEXIUM	Esomeprazole magnesium	Cardinal Health	NDA	Current
55700-046	NEXIUM	Esomeprazole magnesium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
61919-509	NEXIUM	esomeprazole magnesium	DIRECT RX	NDA	Current
63629-3311	NEXIUM	Esomeprazole magnesium	Bryant Ranch Prepack	NDA	Current
63629-3311	NEXIUM	Esomeprazole magnesium	Bryant Ranch Prepack	NDA	Current
70518-2038	NEXIUM	Esomeprazole magnesium	REMEDYREPACK INC.	NDA	Current
70518-2038	NEXIUM	Esomeprazole magnesium	REMEDYREPACK INC.	NDA	Current
70518-2038	NEXIUM	Esomeprazole magnesium	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74834	SUPPL	2023-07-20
74833	SUPPL	2023-07-20
74798	SUPPL	2023-07-19
70461	SUPPL	2022-03-10
70456	SUPPL	2022-03-10
70411	SUPPL	2022-03-07
68487	SUPPL	2021-08-31
68486	SUPPL	2021-08-31
68477	SUPPL	2021-08-27
65407	SUPPL	2020-11-30
65406	SUPPL	2020-11-30
65379	SUPPL	2020-11-30
54568	SUPPL	2018-06-14
54503	SUPPL	2018-06-11
54498	SUPPL	2018-06-11
46480	SUPPL	2016-12-22
46488	SUPPL	2016-12-21
45693	SUPPL	2016-10-28
45660	SUPPL	2016-10-26
36230	SUPPL	2014-12-29
26927	SUPPL	2014-12-24
41992	SUPPL	2014-08-05
21481	SUPPL	2014-08-05
21480	SUPPL	2014-08-05
36229	SUPPL	2014-04-01
4493	SUPPL	2014-03-28
14527	SUPPL	2014-03-05
26926	SUPPL	2014-02-27
14526	SUPPL	2012-12-10
26925	SUPPL	2012-11-29
41990	SUPPL	2012-10-12
14524	SUPPL	2012-10-12
4491	SUPPL	2012-10-11
4492	SUPPL	2012-10-02
14525	SUPPL	2012-10-01
26924	SUPPL	2012-01-24
14523	SUPPL	2012-01-24
44101	ORIG	2011-12-20
26923	SUPPL	2011-07-06
14522	SUPPL	2011-07-06
14521	SUPPL	2011-06-29
4489	SUPPL	2011-06-27
36228	SUPPL	2010-09-10
4490	SUPPL	2010-09-09
4488	SUPPL	2010-03-08
14520	SUPPL	2010-03-05
4487	SUPPL	2009-11-25
36227	SUPPL	2009-10-14
26922	SUPPL	2009-01-21
14519	SUPPL	2009-01-16
51725	ORIG	2008-10-02
41991	SUPPL	2008-02-19
26921	SUPPL	2008-01-18
36226	SUPPL	2007-05-01
14518	SUPPL	2007-05-01
4486	SUPPL	2007-05-01
51724	ORIG	2007-03-29
4484	SUPPL	2006-10-18
36225	SUPPL	2006-10-13
26920	SUPPL	2006-10-02
14517	SUPPL	2006-09-27
4485	SUPPL	2006-09-20
14516	SUPPL	2006-09-18
26919	SUPPL	2006-05-02
14515	SUPPL	2006-05-02
26918	SUPPL	2006-03-01
14514	SUPPL	2006-02-22
51723	ORIG	2005-12-20
51722	ORIG	2005-12-20
14513	SUPPL	2005-06-08
4483	SUPPL	2005-06-08
36224	SUPPL	2004-12-03
26917	SUPPL	2004-12-02
14512	SUPPL	2004-05-04
26916	SUPPL	2004-04-29
41989	SUPPL	2004-04-14
36223	SUPPL	2004-01-15
4482	SUPPL	2004-01-14
26915	SUPPL	2003-03-10
4481	SUPPL	2002-09-20
51721	ORIG	2001-12-31
41988	ORIG	2001-02-20
36222	ORIG	2001-02-20
26914	ORIG	2001-02-20
67176	ORIG	1900-01-01