Application 021153

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Related Records

Company: ASTRAZENECA PHARMS

Application Products

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

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
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
0186-0382	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 Pharmaceutica	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
0186-5040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-5040	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
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
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