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 2 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quetiapine fumarateQUETIAPINE FUMARATESun Pharmaceutical Industries, Inc.ffe52b98-9872-48c1-90fd-8fcd37c3432f2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack58541ffd-58c3-49aa-ad90-7e91a3c0b7d62026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackd3dcfb51-e67d-44dc-9186-4729f6414bf12026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine fumarateQUETIAPINE FUMARATECoupler LLC5074c897-bcf9-7497-e063-6394a90aa7332026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackaa0d27fd-569a-4573-b45d-2de5f5a302942026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.b84e1614-b077-4ea5-8d11-df68f2b926de2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepack897184b1-de3c-4d59-91be-3069325fd5b22026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.da5c118f-404c-4453-aa10-a8656b1d75012026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.911bf26c-a89a-4ce1-8ff5-cfda03d0a4822026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
SEROQUEL XRQUETIAPINEH2-Pharma, LLCab959a35-d0ba-4f18-8f2e-6619d88b16e32026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SEROQUEL XR
Quetiapine FumarateQUETIAPINE FUMARATEBryant Ranch Prepackf0ad842c-a0c2-4855-a55b-353b5338980f2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEREMEDYREPACK INC.41dbd5a5-4ae2-4ac1-8135-0fdac5c170b52026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.16f48034-b8c9-ab2b-e063-6294a90adf652026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepacka45d8b77-f13d-41c5-8d50-15152fc6f85c2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f2026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack45c4c3a4-3acc-413e-9746-4816d513fac62026-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEXLCare Pharmaceuticals Inc.070faf07-0ce7-4354-8643-9d222b72ecad2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions55018271-1f8f-4683-afee-8203c3bd9acc2026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEDirect_Rxf6de1d2b-b10e-2e9a-e053-6394a90a735d2026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: QUETIAPINE FUMARATE
Quetiapine FumarateQUETIAPINE FUMARATEA-S Medication Solutions42bd7dd3-9f81-4d8b-bce9-302e5559da2f2026-02-17Boxed 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