HOSPIRA FDA Approval ANDA 089565

ANDA 089565

HOSPIRA

FDA Drug Application

Application #089565

Application Sponsors

ANDA 089565HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10MG/VIAL0VINBLASTINE SULFATEVINBLASTINE SULFATE

FDA Submissions

ORIG1AP1987-08-18
LABELING; LabelingSUPPL2AP1989-09-22
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1992-09-30
LABELING; LabelingSUPPL4AP1990-01-12
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1992-12-23
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1992-12-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1992-07-22
LABELING; LabelingSUPPL8AP1992-09-30
LABELING; LabelingSUPPL9AP1993-04-14
LABELING; LabelingSUPPL10AP1993-04-14
LABELING; LabelingSUPPL11AP1995-01-11
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1995-04-28
LABELING; LabelingSUPPL13AP1997-09-11
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2000-05-12
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2000-08-08
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2001-07-30
LABELING; LabelingSUPPL22AP2001-09-25

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL12Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89565
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VINBLASTINE SULFATE","activeIngredients":"VINBLASTINE SULFATE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VINBLASTINE SULFATE","submission":"VINBLASTINE SULFATE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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