Application 022047

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEROQUEL XR	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	Yes	No
002	SEROQUEL XR	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 200MG BASE	Yes	Yes
003	SEROQUEL XR	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 300MG BASE	Yes	No
004	SEROQUEL XR	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 400MG BASE	Yes	No
005	SEROQUEL XR	QUETIAPINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022047-001	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-002	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17
N022047-003	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-004	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17
N022047-005	SEROQUEL XR	QUETIAPINE FUMARATE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022047-001	AB
N022047-002	AB
N022047-003	AB
N022047-004	AB
N022047-005	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 6 · 205 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	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-001	SEROQUEL XR	EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-002	SEROQUEL XR	EQ 200MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-003	SEROQUEL XR	EQ 300MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-004	SEROQUEL XR	EQ 400MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2007-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-005	SEROQUEL XR	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-08-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N022047-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022047-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022047-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022047-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022047-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022047-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022047-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022047-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022047-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022047-005	AB	1	`5bbf6a4d5a75…`

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 XR	QUETIAPINE	H2-Pharma, LLC	ab959a35-d0ba-4f18-8f2e-6619d88b16e3	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022047 application number: NDA022047
SEROQUEL XR	QUETIAPINE	AstraZeneca Pharmaceuticals LP	473a3ac4-67f4-4782-baa9-7f9bdd8761f4	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022047 application number: NDA022047 ndc (product): 0310-0282 ndc (product): 0310-0281 ndc (product): 0310-0280 ndc (product): 0310-0284 ndc (product): 0310-0283

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 74 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0280	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0280	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0281	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0282	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0283	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	quetiapine	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0284	SEROQUEL	quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0297	SEROQUEL	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-8280	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8280	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8280	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8280	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8281	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8281	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8281	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8281	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8282	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8282	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8282	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8282	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8283	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8283	Quetiapine Fumarate	Quetiapine Fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8283	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8283	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8283	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8284	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8284	Quetiapine Fumarate	Quetiapine Fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8284	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8284	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
0310-8284	Quetiapine Fumarate	Quetiapine fumarate	AstraZeneca Pharmaceuticals LP	NDA AUTHORIZED GENERIC	Current
49884-805	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-805	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-806	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-806	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-807	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-807	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-808	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-808	Quetiapine Fumarate	Quetiapine fumarate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
64725-0280	SEROQUEL	Quetiapine fumarate	TYA Pharmaceuticals	NDA	Current
64725-0281	SEROQUEL	Quetiapine fumarate	TYA Pharmaceuticals	NDA	Current
64725-0282	SEROQUEL	Quetiapine fumarate	TYA Pharmaceuticals	NDA	Current
64725-0283	SEROQUEL	Quetiapine fumarate	TYA Pharmaceuticals	NDA	Current
64725-0284	SEROQUEL	Quetiapine fumarate	TYA Pharmaceuticals	NDA	Current
69189-0484	SEROQUEL	Quetiapine fumarate	Avera McKennan Hospital	NDA	Current
70518-0646	Quetiapine Fumarate	Quetiapine fumarate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-0646	Quetiapine Fumarate	Quetiapine fumarate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81061	SUPPL	2025-02-06
80939	SUPPL	2025-02-05
80938	SUPPL	2025-02-05
69995	SUPPL	2022-01-31
69989	SUPPL	2022-01-28
69988	SUPPL	2022-01-28
64656	SUPPL	2020-09-22
64655	SUPPL	2020-09-22
64634	SUPPL	2020-09-21
64633	SUPPL	2020-09-21
63256	SUPPL	2020-05-22
63255	SUPPL	2020-05-22
63207	SUPPL	2020-05-21
61841	SUPPL	2020-02-07
61803	SUPPL	2020-02-06
59854	SUPPL	2019-08-27
59853	SUPPL	2019-08-27
59849	SUPPL	2019-08-27
56816	SUPPL	2018-12-20
56815	SUPPL	2018-12-20
56596	SUPPL	2018-11-30
56595	SUPPL	2018-11-30
56594	SUPPL	2018-11-30
56593	SUPPL	2018-11-30
47374	SUPPL	2017-03-02
47306	SUPPL	2017-02-24
16840	SUPPL	2016-06-21
6770	SUPPL	2016-06-21
16839	SUPPL	2016-05-25
21918	SUPPL	2014-08-01
16838	SUPPL	2013-10-31
29152	SUPPL	2013-10-30
29151	SUPPL	2013-05-02
29150	SUPPL	2013-05-02
6769	SUPPL	2013-05-02
6767	SUPPL	2013-05-02
38145	SUPPL	2013-05-01
38144	SUPPL	2013-05-01
16837	SUPPL	2013-05-01
16835	SUPPL	2013-05-01
44169	ORIG	2011-12-22
6768	SUPPL	2011-11-14
6759	ORIG	2011-09-28
21917	ORIG	2011-09-27
38141	SUPPL	2011-07-12
29149	SUPPL	2011-07-12
16836	SUPPL	2011-07-12
6764	SUPPL	2011-07-12
38142	SUPPL	2011-05-23
6765	SUPPL	2011-05-19
6766	SUPPL	2010-12-07
38143	SUPPL	2010-12-04
29148	SUPPL	2009-12-30
29147	SUPPL	2009-12-30
29146	SUPPL	2009-12-30
29144	SUPPL	2009-12-30
6762	SUPPL	2009-12-30
38140	SUPPL	2009-12-11
38139	SUPPL	2009-12-11
38138	SUPPL	2009-12-11
16834	SUPPL	2009-12-11
16833	SUPPL	2009-12-11
38137	SUPPL	2008-11-07
16831	SUPPL	2008-11-07
16830	SUPPL	2008-11-07
29143	SUPPL	2008-10-09
29142	SUPPL	2008-10-09
6760	SUPPL	2008-10-09
16832	SUPPL	2008-08-29
6763	SUPPL	2008-08-19
29145	SUPPL	2008-08-13
6761	SUPPL	2008-05-28
38136	SUPPL	2008-03-17
29141	SUPPL	2008-03-17