PHARMACIA AND UPJOHN FDA Approval NDA 050629

NDA 050629

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050629

Documents

Letter2002-09-25
Letter2002-09-25
Letter2003-05-30
Letter2010-08-09
Letter2011-09-29
Letter2013-11-06
Label2002-09-25
Label2003-05-13
Label2003-05-29
Label2010-07-30
Label2011-09-26
Label2013-11-01
Letter2003-05-30
Label2002-09-25
Label2019-08-12
Letter2019-08-12
Label2019-12-23
Letter2019-12-26
Letter2020-08-31
Label2020-10-29

Application Sponsors

NDA 050629PHARMACIA AND UPJOHN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION2MG/ML1DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE
002INJECTABLE;INJECTION200MG/100ML1DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE
003INJECTABLE;INJECTION150MG/75ML1DOXORUBICIN HYDROCHLORIDEDOXORUBICIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1987-12-23PRIORITY
LABELING; LabelingSUPPL2AP1994-11-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-05-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-09-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-09-15PRIORITY
LABELING; LabelingSUPPL6AP1998-02-13STANDARD
LABELING; LabelingSUPPL7AP1999-03-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-08-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-08-10PRIORITY
LABELING; LabelingSUPPL10AP2002-09-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-01-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-04-02PRIORITY
LABELING; LabelingSUPPL13AP2002-09-25STANDARD
EFFICACY; EfficacySUPPL14AP2003-05-08STANDARD
LABELING; LabelingSUPPL16AP2003-05-08STANDARD
LABELING; LabelingSUPPL17AP2010-07-30UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2011-03-28N/A
LABELING; LabelingSUPPL19AP2011-09-26UNKNOWN
LABELING; LabelingSUPPL22AP2013-10-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2013-10-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2013-10-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2014-12-05PRIORITY
LABELING; LabelingSUPPL28AP2019-12-20STANDARD
LABELING; LabelingSUPPL29AP2019-08-09STANDARD
LABELING; LabelingSUPPL30TA2020-03-17STANDARD

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL17Null7
SUPPL18Null6
SUPPL19Null15
SUPPL22Null7
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL28Null7
SUPPL29Null15
SUPPL30Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PFIZER
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50629
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DOXORUBICIN HYDROCHLORIDE","activeIngredients":"DOXORUBICIN HYDROCHLORIDE","strength":"150MG\/75ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/28\/2020","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050467s078,050629s030lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050629s028lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/050629s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050629s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050629s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/050629s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2010","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050629s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2003","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2003","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/050467s068lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50467s64s67,50629s10s13lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2002","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/50467s64s67,50629s10s13lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DOXORUBICIN HYDROCHLORIDE","submission":"DOXORUBICIN HYDROCHLORIDE","actionType":"150MG\/75ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-08-28
        )

)
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