Application 204655

Type: NDA
Sponsor: ASTRAZENECA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	CAPSULE, DELAYED RELEASE;ORAL	EQ 20MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N204655-001	NEXIUM 24HR	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2014-03-28

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204655-001	NEXIUM 24HR	EQ 20MG BASE	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2014-03-28	`e64feba35796…`

Observed Orange Book patent history#

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	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810	2019-11-03	U-1874	Drug product	2014-04-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810	2019-11-03	U-1509	Drug product	2014-04-24	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204655-001	6428810*PED	2020-05-03		Pediatric extension		`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
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	d56b330a-4355-4636-9d26-c592f67cea56	2024-05-14	Warnings	Exact identifier application applno (NDA): 204655 application number: NDA204655 ndc (product): 50090-1492
Nexium 24HR	ESOMEPRAZOLE MAGNESIUM	Haleon US Holdings LLC	4513934d-0cf0-40fc-a348-b4e75a33b094	2024-03-19	Warnings	Exact identifier application applno (NDA): 204655 application number: NDA204655 ndc (product): 0573-2452 ndc (product): 0573-2450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-2450	Nexium 24HR	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	Wyeth Consumer Healthcare LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	Wyeth Consumer Healthcare LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	Wyeth Consumer Healthcare	NDA	Current
0573-2450	Nexium 24HR	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	Wyeth Consumer Healthcare LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	Wyeth Consumer Healthcare LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	Wyeth Consumer Healthcare	NDA	Current
0573-2452	Nexium 24HR ClearMinis	esomeprazole magnesium	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
50090-1460	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1460	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1460	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1460	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1461	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1492	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1492	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1492	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current
50090-1492	Nexium 24HR	esomeprazole magnesium	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72057	SUPPL	2022-09-09
72020	SUPPL	2022-09-07
65524	SUPPL	2020-12-08
58246	SUPPL	2019-04-08
58245	SUPPL	2019-04-08
52422	SUPPL	2018-02-06
51906	SUPPL	2018-01-26
47105	SUPPL	2017-02-06
47104	SUPPL	2017-02-06
46953	SUPPL	2017-01-24
46854	SUPPL	2017-01-17
19583	SUPPL	2015-06-03
24477	ORIG	2014-12-09
22960	ORIG	2014-12-09
40408	SUPPL	2014-10-06
10376	SUPPL	2014-10-06
10375	ORIG	2014-04-02
40407	ORIG	2014-03-31