FDA.reportPublic FDA data

Application 022047

Type
NDA
Sponsor
ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASEYesNo
002SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 200MG BASEYesYes
003SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 300MG BASEYesNo
004SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 400MG BASEYesNo
005SEROQUEL XRQUETIAPINE FUMARATETABLET, EXTENDED RELEASE;ORALEQ 150MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0280SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0280SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0281SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0282SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0283SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELquetiapineAstraZeneca Pharmaceuticals LPNDACurrent
0310-0284SEROQUELquetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-0297SEROQUELQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDACurrent
0310-8280Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8280Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8280Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8280Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8281Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8281Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8281Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8281Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8282Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8282Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8282Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8282Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8283Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8283Quetiapine FumarateQuetiapine FumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8283Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8283Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8283Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8284Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8284Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8284Quetiapine FumarateQuetiapine FumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8284Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
0310-8284Quetiapine FumarateQuetiapine fumarateAstraZeneca Pharmaceuticals LPNDA AUTHORIZED GENERICCurrent
49884-805Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-805Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-806Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-806Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-807Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-807Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-808Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-808Quetiapine FumarateQuetiapine fumaratePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
64725-0280SEROQUELQuetiapine fumarateTYA PharmaceuticalsNDACurrent
64725-0281SEROQUELQuetiapine fumarateTYA PharmaceuticalsNDACurrent
64725-0282SEROQUELQuetiapine fumarateTYA PharmaceuticalsNDACurrent
64725-0283SEROQUELQuetiapine fumarateTYA PharmaceuticalsNDACurrent
64725-0284SEROQUELQuetiapine fumarateTYA PharmaceuticalsNDACurrent
69189-0484SEROQUELQuetiapine fumarateAvera McKennan HospitalNDACurrent
70518-0646Quetiapine FumarateQuetiapine fumarateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-0646Quetiapine FumarateQuetiapine fumarateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81061SUPPL 2025-02-06
80939SUPPL 2025-02-05
80938SUPPL 2025-02-05
69995SUPPL2022-01-31
69989SUPPL2022-01-28
69988SUPPL2022-01-28
64656SUPPL2020-09-22
64655SUPPL2020-09-22
64634SUPPL2020-09-21
64633SUPPL2020-09-21
63256SUPPL2020-05-22
63255SUPPL2020-05-22
63207SUPPL2020-05-21
61841SUPPL2020-02-07
61803SUPPL2020-02-06
59854SUPPL2019-08-27
59853SUPPL2019-08-27
59849SUPPL2019-08-27
56816SUPPL2018-12-20
56815SUPPL2018-12-20
56596SUPPL2018-11-30
56595SUPPL2018-11-30
56594SUPPL2018-11-30
56593SUPPL2018-11-30
47374SUPPL2017-03-02
47306SUPPL2017-02-24
16840SUPPL2016-06-21
6770SUPPL2016-06-21
16839SUPPL2016-05-25
21918SUPPL2014-08-01
16838SUPPL2013-10-31
29152SUPPL2013-10-30
29151SUPPL2013-05-02
29150SUPPL2013-05-02
6769SUPPL2013-05-02
6767SUPPL2013-05-02
38145SUPPL2013-05-01
38144SUPPL2013-05-01
16837SUPPL2013-05-01
16835SUPPL2013-05-01
44169ORIG2011-12-22
6768SUPPL2011-11-14
6759ORIG2011-09-28
21917ORIG2011-09-27
38141SUPPL2011-07-12
29149SUPPL2011-07-12
16836SUPPL2011-07-12
6764SUPPL2011-07-12
38142SUPPL2011-05-23
6765SUPPL2011-05-19
6766SUPPL2010-12-07
38143SUPPL2010-12-04
29148SUPPL2009-12-30
29147SUPPL2009-12-30
29146SUPPL2009-12-30
29144SUPPL2009-12-30
6762SUPPL2009-12-30
38140SUPPL2009-12-11
38139SUPPL2009-12-11
38138SUPPL2009-12-11
16834SUPPL2009-12-11
16833SUPPL2009-12-11
38137SUPPL2008-11-07
16831SUPPL2008-11-07
16830SUPPL2008-11-07
29143SUPPL2008-10-09
29142SUPPL2008-10-09
6760SUPPL2008-10-09
16832SUPPL2008-08-29
6763SUPPL2008-08-19
29145SUPPL2008-08-13
6761SUPPL2008-05-28
38136SUPPL2008-03-17
29141SUPPL2008-03-17