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 4 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack45947f72-d870-4f6e-9e5f-38d6b324d5fe2025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack35b2069e-209a-41ac-84e6-377d4f19be872025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack9a024071-e620-48e8-9f22-d4cda5dc5ab12025-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.951a098a-d905-4723-89e1-71bf1551dcb62025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEGolden State Medical Supply, Inc.6fc9c8e2-6f34-aa43-e053-2a91aa0ac3772025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack1618989e-2e6b-49ff-81b5-cf80d1dcfab42025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATENCS HealthCare of KY, LLC dba Vangard Labsd73655d3-4b3f-40b4-92cb-053ad4f21a922025-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEUnichem Pharmaceuticals (USA), Inc.bdc9354b-172e-4bb3-895a-6c7cfef0ef142025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.69275af7-1469-4405-a98e-e8b0f8d42dd92025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEHikma Pharmaceuticals USA Inc.271e9fb7-3c70-43fc-8279-5adf189f3c222025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack35f6ad40-192a-4d1f-ace0-9fb69b9d984d2025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack385f7c3d-3299-4b04-947e-de2ee78c82412025-01-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect Rxdb48ec02-1119-f343-e053-2a95a90afb3b2025-01-22Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxface6c19-3dd9-b188-e053-6294a90a62d02025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxfceb9f47-8da7-7138-e053-6294a90a55582025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
SEROQUEL XRQUETIAPINEAstraZeneca Pharmaceuticals LP473a3ac4-67f4-4782-baa9-7f9bdd8761f42025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SEROQUEL XR
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.8acc0ed3-6e4f-4799-8252-5a163938fddc2025-01-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAdvanced Rx Pharmacy of Tennessee, LLCd323b6c0-55fa-6caa-e053-2a95a90a3cff2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAdvanced Rx Pharmacy of Tennessee, LLCd2a76aed-a0b8-33f0-e053-2a95a90add0f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions132a2483-7e49-4b0c-9db4-e6e578697fd92024-12-20Boxed 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