HOSPIRA FDA Approval ANDA 088368

ANDA 088368

HOSPIRA

FDA Drug Application

Application #088368

Application Sponsors

ANDA 088368HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION20%0LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1984-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-08-15
LABELING; LabelingSUPPL3AP1990-06-14
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1990-06-14
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-10-03
LABELING; LabelingSUPPL8AP2002-12-04

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88368
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"20%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"20%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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