Application 021689

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Related Records

Company: ASTRAZENECA PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEXIUM IV	ESOMEPRAZOLE SODIUM	INJECTABLE;INTRAVENOUS	EQ 20MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	NEXIUM IV	ESOMEPRAZOLE SODIUM	INJECTABLE;INTRAVENOUS	EQ 40MG BASE/VIAL	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-6020	NEXIUM	Esomeprazole sodium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-6040	NEXIUM	Esomeprazole sodium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-6040	NEXIUM	Esomeprazole sodium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-6040	NEXIUM	Esomeprazole sodium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-6040	NEXIUM	Esomeprazole sodium	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents

Document	Submission type	Date
74816	SUPPL	2023-07-20
74779	SUPPL	2023-07-19
72843	SUPPL	2022-12-09
70462	SUPPL	2022-03-10
70416	SUPPL	2022-03-07
65401	SUPPL	2020-11-30
65384	SUPPL	2020-11-30
60182	SUPPL	2020-01-14
60173	SUPPL	2019-10-01
55365	SUPPL	2018-08-30
55183	SUPPL	2018-08-16
46478	SUPPL	2016-12-22
46493	SUPPL	2016-12-21
45712	SUPPL	2016-10-31
45653	SUPPL	2016-10-26
37470	SUPPL	2014-12-29
5994	SUPPL	2014-12-23
5992	SUPPL	2014-04-14
15993	SUPPL	2014-04-01
28381	SUPPL	2014-03-06
15994	SUPPL	2014-03-05
15990	SUPPL	2014-03-05
5993	SUPPL	2014-02-27
37468	SUPPL	2012-10-12
28387	SUPPL	2012-10-12
28388	SUPPL	2012-10-02
37469	SUPPL	2012-10-01
28386	SUPPL	2012-01-24
15992	SUPPL	2012-01-24
44143	ORIG	2011-12-20
37467	SUPPL	2011-07-06
28385	SUPPL	2011-07-06
37465	SUPPL	2011-06-29
28383	SUPPL	2011-06-27
5991	SUPPL	2011-05-04
15991	SUPPL	2011-04-29
37466	SUPPL	2010-09-10
28384	SUPPL	2010-09-08
28382	SUPPL	2010-03-08
37464	SUPPL	2010-03-05
28380	SUPPL	2009-01-21
5990	SUPPL	2009-01-21
37463	SUPPL	2009-01-16
15989	SUPPL	2009-01-16
42271	ORIG	2007-08-06
15988	SUPPL	2007-05-01
15987	SUPPL	2007-05-01
5989	SUPPL	2007-05-01
28379	SUPPL	2006-10-02
37462	SUPPL	2006-09-27
5988	SUPPL	2006-09-20
15986	SUPPL	2006-09-18
28378	SUPPL	2006-03-01
37461	SUPPL	2006-02-22
5987	SUPPL	2006-01-20
37460	SUPPL	2006-01-13
37459	ORIG	2005-04-06
28377	ORIG	2005-04-06
53267	ORIG	1900-01-01
53266	ORIG	1900-01-01