HOSPIRA FDA Approval ANDA 088367

ANDA 088367

HOSPIRA

FDA Drug Application

Application #088367

Application Sponsors

ANDA 088367HOSPIRA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10%0LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERLIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1984-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-08-01
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-08-01
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-10-14
LABELING; LabelingSUPPL5AP1990-04-18
LABELING; LabelingSUPPL7AP1991-07-23
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-10-03
LABELING; LabelingSUPPL11AP2002-01-02

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL9Null0
SUPPL11Null0

CDER Filings

HOSPIRA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88367
            [companyName] => HOSPIRA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"10%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"10%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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