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 5 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackd779f317-683b-4ec6-a309-1dd54332563f2024-08-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEAdvanced Rx of Tennessee, LLC1cfc847b-0d8d-fc94-e063-6394a90a311f2024-07-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEBryant Ranch Prepack293a9857-d138-4583-abc9-35b75660e3242024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATECamber Pharmaceuticals, Inc.5c6aeb85-3ac2-4448-b544-9a4c5f562ed32024-04-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions845159aa-1ac2-41b7-ac21-d4b03e43203b2024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP392dd5cf-4777-4985-b62b-7370134dee262024-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.0fdbe32f-d04a-5666-e063-6294a90a8e362024-01-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutionsccacb909-8ee5-4223-bfee-9cfeae470ecf2023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP2b387188-c2c1-4865-984c-341a358d1c6c2023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP85f973e0-93e6-4856-9266-62136acb25322023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions95156201-ed16-4806-98a7-d42acc9021262023-06-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LPc1f2ccba-62f3-44e7-b06f-dea61eac9e932023-04-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEMacleods Pharmaceuticals Limited531cbe20-dff2-4983-9788-4543079f83ff2023-03-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAlembic Pharmaceuticals Limited93ab6237-321e-4a2c-b0ca-3fc9acb31f9a2023-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP1a147d6c-8af8-4379-8a13-1864a9a79b842022-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP8048ac0a-5d4d-4d00-ab9c-7fcac27f0a602022-05-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEAphena Pharma Solutions - Tennessee, LLC60316ccd-c042-4ea0-9d05-3caf7cc2cab12021-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEProficient Rx LP03517f29-f270-4350-a57a-fbe1967b00962019-10-01Boxed 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