TARO FDA Approval ANDA 086256

ANDA 086256

TARO

FDA Drug Application

Application #086256

Application Sponsors

ANDA 086256TARO

Marketing Status

Discontinued001

Application Products

001OINTMENT;TOPICAL0.5%0HYDROCORTISONEHYDROCORTISONE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL5AP1982-05-24
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1984-07-03

Submissions Property Types

SUPPL5Null0
SUPPL6Null0

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86256
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCORTISONE","activeIngredients":"HYDROCORTISONE","strength":"0.5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCORTISONE","submission":"HYDROCORTISONE","actionType":"0.5%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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