PHARMACIA AND UPJOHN FDA Approval NDA 018102

NDA 018102

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018102

Application Sponsors

NDA 018102PHARMACIA AND UPJOHN

Marketing Status

Discontinued001

Application Products

001ENEMA;RECTAL40MG/BOT0MEDROLMETHYLPREDNISOLONE ACETATE

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP1977-12-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1981-04-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1982-11-19STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18102
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDROL","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/BOT","dosageForm":"ENEMA;RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEDROL","submission":"METHYLPREDNISOLONE ACETATE","actionType":"40MG\/BOT","submissionClassification":"ENEMA;RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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