Application 021957

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	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 20MG BASE/PACKET	Yes	No
002	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 40MG BASE/PACKET	Yes	Yes
003	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 2.5MG BASE/PACKET	Yes	No
004	NEXIUM	ESOMEPRAZOLE MAGNESIUM	FOR SUSPENSION, DELAYED RELEASE;ORAL	EQ 5MG BASE/PACKET	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4020	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4025	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4040	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceutica	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-4050	NEXIUM	Esomeprazole magnesium	AstraZeneca Pharmaceuticals LP	NDA	Current
61919-509	NEXIUM	esomeprazole magnesium	DIRECT RX	ANDA	Current

Documents

Document	Submission type	Date
74836	SUPPL	2023-07-20
74835	SUPPL	2023-07-20
74799	SUPPL	2023-07-19
74774	SUPPL	2022-03-10
70458	SUPPL	2022-03-10
70457	SUPPL	2022-03-10
70412	SUPPL	2022-03-07
68489	SUPPL	2021-08-31
68488	SUPPL	2021-08-31
68478	SUPPL	2021-08-27
65409	SUPPL	2020-11-30
65408	SUPPL	2020-11-30
65380	SUPPL	2020-11-30
54566	SUPPL	2018-06-14
54501	SUPPL	2018-06-11
54500	SUPPL	2018-06-11
46479	SUPPL	2016-12-22
46487	SUPPL	2016-12-21
45695	SUPPL	2016-10-28
45662	SUPPL	2016-10-26
37956	SUPPL	2014-12-29
28924	SUPPL	2014-12-24
16641	SUPPL	2014-04-01
28923	SUPPL	2014-03-28
16642	SUPPL	2014-03-05
6544	SUPPL	2014-02-27
37955	SUPPL	2012-12-10
28922	SUPPL	2012-11-29
37953	SUPPL	2012-10-12
6542	SUPPL	2012-10-11
6543	SUPPL	2012-10-02
37954	SUPPL	2012-10-01
28921	SUPPL	2012-01-24
16640	SUPPL	2012-01-24
28916	SUPPL	2011-12-28
37949	SUPPL	2011-12-23
44161	ORIG	2011-12-20
28920	SUPPL	2011-07-06
16639	SUPPL	2011-07-06
37952	SUPPL	2011-06-29
6541	SUPPL	2011-06-27
28917	SUPPL	2010-09-23
16638	SUPPL	2010-09-10
28919	SUPPL	2010-09-09
28918	SUPPL	2010-03-08
37951	SUPPL	2010-03-05
37950	SUPPL	2009-06-24
6540	SUPPL	2009-01-21
16637	SUPPL	2009-01-16
21885	ORIG	2008-09-05
28915	SUPPL	2008-01-18
37948	ORIG	2007-03-27
28914	ORIG	2006-10-26
53265	SUPPL	1900-01-01
53264	SUPPL	1900-01-01