Application 020639

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Related Records

Company: ASTRAZENECA PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes
002	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 100MG BASE	Yes	No
003	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 200MG BASE	Yes	No
004	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 300MG BASE	Yes	Yes
006	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 400MG BASE	Yes	No
007	SEROQUEL	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 50MG BASE	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0271	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0272	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0274	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0275	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0278	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0279	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
21695-117	SEROQUEL	Quetiapine fumarate	Rebel Distributors Corp	NDA	Current
21695-118	SEROQUEL	Quetiapine fumarate	Rebel Distributors Corp	NDA	Current
21695-119	SEROQUEL	Quetiapine fumarate	Rebel Distributors Corp	NDA	Current
21695-120	SEROQUEL	Quetiapine fumarate	Rebel Distributors Corp	NDA	Current
55289-187	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, In	NDA	Current
55289-187	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-187	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, In	NDA	Current
55289-447	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-447	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-872	SEROQUEL	Quetiapine fumarate	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-3291	SEROQUEL	quetiapine	Bryant Ranch Prepack	NDA	Current
63629-3291	SEROQUEL	Quetiapine fumarate	Bryant Ranch Prepack	NDA	Current
63629-3319	SEROQUEL	Quetiapine fumarate	Bryant Ranch Prepack	NDA	Current
63629-3378	SEROQUEL	Quetiapine fumarate	Bryant Ranch Prepack	NDA	Current
63629-3380	SEROQUEL	Quetiapine fumarate	Bryant Ranch Prepack	NDA	Current
67046-660	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
67046-661	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
67046-662	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
67046-663	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
67046-664	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
67046-666	SEROQUEL	Quetiapine fumarate	Contract Pharmacy Services-PA	NDA	Current
70518-2166	SEROQUEL	Quetiapine fumarate	REMEDYREPACK INC.	NDA	Current
70518-2166	SEROQUEL	Quetiapine fumarate	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
81060	SUPPL	2025-02-06
80941	SUPPL	2025-02-05
80940	SUPPL	2025-02-05
70010	SUPPL	2022-01-31
70008	SUPPL	2022-01-31
69994	SUPPL	2022-01-31
64654	SUPPL	2020-09-22
64653	SUPPL	2020-09-22
64632	SUPPL	2020-09-21
62710	SUPPL	2020-04-28
62363	SUPPL	2020-03-30
61840	SUPPL	2020-02-07
61839	SUPPL	2020-02-07
61802	SUPPL	2020-02-06
59852	SUPPL	2019-08-27
59851	SUPPL	2019-08-27
59848	SUPPL	2019-08-27
58919	SUPPL	2019-06-03
56814	SUPPL	2018-12-20
56813	SUPPL	2018-12-20
56592	SUPPL	2018-11-30
56591	SUPPL	2018-11-30
56590	SUPPL	2018-11-30
56589	SUPPL	2018-11-30
47373	SUPPL	2017-03-02
47305	SUPPL	2017-02-24
12916	SUPPL	2016-06-21
2985	SUPPL	2016-06-21
12915	SUPPL	2013-10-31
25427	SUPPL	2013-10-30
25426	SUPPL	2013-05-02
25425	SUPPL	2013-05-02
25423	SUPPL	2013-05-02
2984	SUPPL	2013-05-02
35064	SUPPL	2013-05-01
35063	SUPPL	2013-05-01
12914	SUPPL	2013-05-01
12913	SUPPL	2013-05-01
20802	SUPPL	2012-03-07
20801	SUPPL	2012-03-07
44456	ORIG	2011-12-22
2983	SUPPL	2011-11-14
41516	SUPPL	2011-09-22
35062	SUPPL	2011-07-12
35060	SUPPL	2011-07-12
25424	SUPPL	2011-07-12
25422	SUPPL	2011-07-12
35061	SUPPL	2011-05-23
2981	SUPPL	2011-05-19
2982	SUPPL	2010-12-06
12912	SUPPL	2010-12-04
25421	SUPPL	2010-01-27
2980	SUPPL	2010-01-27
35059	SUPPL	2009-12-11
12911	SUPPL	2009-12-11
23174	ORIG	2009-11-20
25418	SUPPL	2008-10-28
2979	SUPPL	2008-08-19
24179	SUPPL	2008-07-16
35058	SUPPL	2008-06-05
35057	SUPPL	2008-06-05
35056	SUPPL	2008-06-05
12910	SUPPL	2008-06-05
25417	SUPPL	2008-05-14
2978	SUPPL	2008-05-14
2977	SUPPL	2008-05-14
2976	SUPPL	2008-05-14
25420	SUPPL	2008-01-30
2975	SUPPL	2008-01-30
41515	SUPPL	2007-11-19
20800	SUPPL	2007-11-19
25419	SUPPL	2007-08-02
41514	ORIG	2007-07-17
23587	ORIG	2007-05-09
12909	SUPPL	2006-10-23
2974	SUPPL	2006-10-23
2973	SUPPL	2006-09-25
12908	SUPPL	2006-09-21
25416	SUPPL	2006-02-08
35055	SUPPL	2004-07-21
2972	SUPPL	2004-07-21
35054	SUPPL	2004-01-15
12907	SUPPL	2004-01-15
25415	SUPPL	2004-01-14
2971	SUPPL	2004-01-14
2970	SUPPL	2001-03-27
64054	ORIG	1900-01-01
64053	ORIG	1900-01-01
53025	SUPPL	1900-01-01
53024	SUPPL	1900-01-01
53023	SUPPL	1900-01-01
53022	SUPPL	1900-01-01
53021	SUPPL	1900-01-01
51629	SUPPL	1900-01-01
51627	SUPPL	1900-01-01
51626	SUPPL	1900-01-01
51625	SUPPL	1900-01-01