Application 022101

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 10MG BASE/PACKET	Yes	No

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
N022101-001	NEXIUM	ESOMEPRAZOLE MAGNESIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2008-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022101-001	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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	N022101-001	NEXIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2008-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022101-001	NEXIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2008-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022101-001	NEXIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2008-02-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022101-001	NEXIUM	EQ 10MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD	2008-02-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022101-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022101-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022101-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022101-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022101-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022101-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022101-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022101-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022101-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022101-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022101-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022101-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022101-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022101-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022101-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022101-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022101-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022101-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022101-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022101-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022101-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022101-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022101-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022101-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022101-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022101-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022101-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022101-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022101-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022101-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022101-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022101-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022101-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022101-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022101-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022101-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022101-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022101-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022101-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022101-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

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	N022101-001	6428810	2019-11-03	U-858	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022101-001	6428810*PED	2020-05-03		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022101-001	6428810*PED	2020-05-03		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022101-001	6428810*PED	2020-05-03		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022101-001	6428810	2019-11-03	U-858	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022101-001	6428810*PED	2020-05-03		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022101-001	6428810	2019-11-03	U-858	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022101-001	6428810*PED	2020-05-03		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022101-001	6428810	2019-11-03	U-858	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022101-001	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 · 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): 022101 application number: NDA022101 ndc (product): 0186-4010

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4010	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74838	SUPPL	2023-07-20
74837	SUPPL	2023-07-20
74800	SUPPL	2023-07-19
70460	SUPPL	2022-03-10
70459	SUPPL	2022-03-10
70413	SUPPL	2022-03-07
68491	SUPPL	2021-08-31
68490	SUPPL	2021-08-31
68479	SUPPL	2021-08-27
65411	SUPPL	2020-11-30
65410	SUPPL	2020-11-30
65381	SUPPL	2020-11-30
54567	SUPPL	2018-06-14
54502	SUPPL	2018-06-11
54499	SUPPL	2018-06-11
46481	SUPPL	2016-12-22
46485	SUPPL	2016-12-21
45694	SUPPL	2016-10-28
45661	SUPPL	2016-10-26
38240	SUPPL	2014-12-29
29243	SUPPL	2014-12-24
16932	SUPPL	2014-04-01
6881	SUPPL	2014-03-28
29242	SUPPL	2014-02-27
16933	SUPPL	2014-02-27
38239	SUPPL	2012-12-10
29241	SUPPL	2012-11-29
16931	SUPPL	2012-10-12
6880	SUPPL	2012-10-11
29240	SUPPL	2012-10-02
38238	SUPPL	2012-10-01
38237	SUPPL	2012-01-24
6879	SUPPL	2012-01-24
23698	ORIG	2011-12-20
38236	SUPPL	2011-07-06
29239	SUPPL	2011-07-06
38234	SUPPL	2011-06-29
6877	SUPPL	2011-06-27
38235	SUPPL	2010-09-10
6878	SUPPL	2010-09-09
44677	ORIG	2010-03-17
42413	ORIG	2010-03-17
29238	SUPPL	2010-03-08
38233	SUPPL	2010-03-05
29237	SUPPL	2009-11-25
38232	SUPPL	2009-10-14
29236	SUPPL	2009-01-21
16930	SUPPL	2009-01-16
6876	ORIG	2008-02-29
38231	ORIG	2008-02-28
53263	ORIG	1900-01-01
53262	ORIG	1900-01-01
53261	ORIG	1900-01-01