PERRIGO CO FDA Approval ANDA 089066

ANDA 089066

PERRIGO CO

FDA Drug Application

Application #089066

Application Sponsors

ANDA 089066PERRIGO CO

Marketing Status

Discontinued001

Application Products

001LOTION;TOPICAL1%0STIE-CORTHYDROCORTISONE

FDA Submissions

ORIG1AP1985-11-25
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1986-04-11
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1995-04-14
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1996-02-22
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-08-03
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-08-16
LABELING; LabelingSUPPL13AP2007-11-28

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0

CDER Filings

PERRIGO CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89066
            [companyName] => PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"STIE-CORT","activeIngredients":"HYDROCORTISONE","strength":"1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"STIE-CORT","submission":"HYDROCORTISONE","actionType":"1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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