Application 020639

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
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QUETIAPINE FUMARATE	TABLET;ORAL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020639-001	SEROQUEL	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26
N020639-002	SEROQUEL	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-003	SEROQUEL	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26
N020639-004	SEROQUEL	QUETIAPINE FUMARATE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20
N020639-005	SEROQUEL	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26
N020639-006	SEROQUEL	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04
N020639-007	SEROQUEL	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N020639-001	AB
N020639-002	AB
N020639-003	AB
N020639-005	AB
N020639-006	AB
N020639-007	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 1 of 8 · 287 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
2026-02-19 14:30 UTC	2026-02	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	SEROQUEL	EQ 400MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	SEROQUEL	EQ 50MG BASE	TABLET / ORAL	AB	RLD	2005-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	SEROQUEL	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	SEROQUEL	EQ 100MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	SEROQUEL	EQ 200MG BASE	TABLET / ORAL	AB	RLD	1997-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-004	SEROQUEL	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1998-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	SEROQUEL	EQ 300MG BASE	TABLET / ORAL	AB	RLD, RS	2000-07-26	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020639-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020639-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020639-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020639-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020639-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020639-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020639-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020639-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020639-005	AB	1	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEROQUEL	QUETIAPINE	H2-Pharma, LLC	8ae62aaf-f8c5-417f-baac-0098369ca322	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639
SEROQUEL	QUETIAPINE	AstraZeneca Pharmaceuticals LP	0584dda8-bc3c-48fe-1a90-79608f78e8a0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020639 application number: NDA020639 ndc (product): 0310-0279 ndc (product): 0310-0274 ndc (product): 0310-0271 ndc (product): 0310-0278 ndc (product): 0310-0272 ndc (product): 0310-0275

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
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
0310-0271	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0271	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 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	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
0310-0275	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 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
0310-0278	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
0310-0278	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
0310-0279	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 table
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