HOSPIRA FDA Approval ANDA 089173

ANDA 089173

HOSPIRA

FDA Drug Application

Application #089173

Application Sponsors

ANDA 089173HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0A-METHAPREDMETHYLPREDNISOLONE SODIUM SUCCINATE

FDA Submissions

ORIG1AP1987-08-18
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1991-08-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1990-11-29
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1990-11-20
LABELING; LabelingSUPPL5AP1990-01-10
LABELING; LabelingSUPPL6AP1992-01-10
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1992-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1992-10-30
LABELING; LabelingSUPPL9AP1993-10-13
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1994-02-04
LABELING; LabelingSUPPL11AP1994-03-17
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1995-05-10
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-10-23

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89173
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"A-METHAPRED","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"A-METHAPRED","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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