FDA.reportPublic FDA data

Application 022172

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL50MGNoNo
002SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL200MGNoNo
003SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL300MGNoNo
004SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE; ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 3 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.479c9555-5d1e-4e5c-bfde-f3812829edd82026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals, Inc.1fe839fa-c566-4374-997f-f5b9d97b5fb82026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATE: Preferred Pharmaceuticals Inc.f3c91d05-038b-40f4-8c1f-2910773ec5672026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATECoupler LLC4872793c-a7be-1b65-e063-6394a90a8b3a2026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEA-S Medication Solutionsaeff3ab1-24ff-417a-8bbc-2ffa413dcb872026-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.471d8e2d-4be6-6180-e063-6394a90ac7212025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAvPAK6b7d7d2f-a50b-8e21-2de4-ccc1020163842025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals, Inc.458cae68-c11d-e760-e063-6394a90ac04e2025-12-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEIngenus Pharmaceuticals, LLC8923c441-c9aa-4b30-89d7-dbaaa7f666562025-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.72111c36-c625-434f-9f16-7f25e0ff75f32025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATEQUETIAPINE FUMARATEAccord Healthcare Inc.3ffe0294-3959-2755-e054-00144ff8d46c2025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATERising Pharma Holdings, Inc.532c8ace-4cf5-4a08-bae7-2af8c41ffa3d2025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATECoupler LLC3eed13b8-7464-3720-e063-6294a90a12452025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack49ebd00b-e0a2-45c3-9cff-4b94d1a6b5ad2025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAurobindo Pharma Limited8df82f5a-aa0e-4f8c-bae1-2f32ede3d7b62025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf75a4d38-ea0e-4780-abf2-67672894a11b2025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxe4ce9d50-9786-2233-e053-2a95a90a276f2025-06-16Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEST. MARY'S MEDICAL PARK PHARMACY3624c430-2a17-a83a-e063-6394a90add932025-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack6efc2886-7dcc-4dac-a212-76078a7efaa72025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATECoupler LLC258eac65-69ed-404f-e063-6394a90a19ef2025-05-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44690ORIG2010-01-05
42436ORIG2010-01-05
23700ORIG2007-12-03
17039ORIG2007-11-19
6996ORIG2007-11-19