HOSPIRA FDA Approval ANDA 088331

ANDA 088331

HOSPIRA

FDA Drug Application

Application #088331

Application Sponsors

ANDA 088331HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION2%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1984-05-17
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-08-01
LABELING; LabelingSUPPL4AP1988-12-23
LABELING; LabelingSUPPL7AP1990-10-03
LABELING; LabelingSUPPL10AP1996-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1996-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1996-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1996-11-13
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1997-01-16
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1996-10-03
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1998-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2000-01-07
LABELING; LabelingSUPPL20AP2000-01-07
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2001-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2001-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2002-10-25

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL7Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88331
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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