BAXTER HLTHCARE CORP FDA Approval NDA 050718

NDA 050718

BAXTER HLTHCARE CORP

FDA Drug Application

Application #050718

Documents

Letter2004-06-02
Letter2007-05-29
Letter2015-04-17
Letter2015-12-29
Label2004-11-01
Label2005-02-03
Label2012-09-20
Label2015-04-17
Letter1999-06-28
Letter2004-10-29
Letter2005-02-03
Letter2007-05-29
Letter2008-06-13
Letter2012-09-24
Letter2013-09-04
Label1999-06-28
Label2007-05-29
Label2007-05-18
Label2008-06-19
Label2013-09-09
Label2015-01-29
Review2011-10-10
Summary Review2008-07-17
Review2017-05-17
Label2017-07-20
Review2017-12-06
Label2019-08-13
Letter2019-08-13
Review2021-04-07
Letter2022-05-09
Label2022-05-11

Application Sponsors

NDA 050718BAXTER HLTHCARE CORP

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE, LIPOSOMAL;INJECTION20MG/10ML (2MG/ML)1DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE
002INJECTABLE, LIPOSOMAL;INJECTION50MG/25ML (2MG/ML)1DOXIL (LIPOSOMAL)DOXORUBICIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1995-11-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-07-10STANDARD
LABELING; LabelingSUPPL4AP1997-07-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-03-31STANDARD
EFFICACY; EfficacySUPPL6AP1999-06-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-03-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-06-13STANDARD
LABELING; LabelingSUPPL10AP2002-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-04-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-08-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2002-12-17STANDARD
EFFICACY; EfficacySUPPL19AP2004-10-27UNKNOWN
EFFICACY; EfficacySUPPL20AP2005-01-28UNKNOWN
LABELING; LabelingSUPPL28AP2007-05-17STANDARD
EFFICACY; EfficacySUPPL29AP2007-05-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2013-12-12STANDARD
EFFICACY; EfficacySUPPL33AP2008-06-10UNKNOWN
LABELING; LabelingSUPPL43AP2012-09-19STANDARD
LABELING; LabelingSUPPL45AP2013-08-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL46AP2015-01-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL47AP2014-04-14STANDARD
EFFICACY; EfficacySUPPL48AP2015-04-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL49AP2015-10-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL50AP2015-12-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL51AP2016-03-29N/A
LABELING; LabelingSUPPL55AP2019-08-12STANDARD
LABELING; LabelingSUPPL60TA2021-11-08STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL2Null14
SUPPL5Null14
SUPPL6Null41
SUPPL7Null14
SUPPL8Null14
SUPPL12Null14
SUPPL14Null14
SUPPL16Null14
SUPPL20Null41
SUPPL31Null14
SUPPL43Null15
SUPPL45Null6
SUPPL46Null14
SUPPL47Null14
SUPPL48Null7
SUPPL49Null14
SUPPL50Null14
SUPPL51Null15
SUPPL55Null15
SUPPL60Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50718
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXIL (LIPOSOMAL)","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"20MG\/10ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"DOXIL (LIPOSOMAL)","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE, LIPOSOMAL;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/12\/2019","submission":"SUPPL-55","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050718s055lbl.pdf\"}]","notes":""},{"actionDate":"03\/29\/2016","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/050718s051lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2015","submission":"SUPPL-48","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050718s048lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2015","submission":"SUPPL-46","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050718s046lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/30\/2013","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050718s045lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2012","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050718s043lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2008","submission":"SUPPL-33","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050718s033lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2007","submission":"SUPPL-29","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050718s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2007","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/050718s028s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2005","submission":"SUPPL-20","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/50718s019,020lbl.pdf\"}]","notes":""},{"actionDate":"10\/27\/2004","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50718s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/1999","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/50718s06lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOXIL (LIPOSOMAL)","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"20MG\/10ML (2MG\/ML)","submissionClassification":"INJECTABLE, LIPOSOMAL;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOXIL (LIPOSOMAL)","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE, LIPOSOMAL;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-12
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.