PHARMACIA AND UPJOHN FDA Approval ANDA 084710

ANDA 084710

PHARMACIA AND UPJOHN

FDA Drug Application

Application #084710

Application Sponsors

ANDA 084710PHARMACIA AND UPJOHN

Marketing Status

Discontinued001

Application Products

001CREAM;VAGINAL1.5MG/GM0OGENESTROPIPATE

FDA Submissions

ORIG1AP1977-06-03
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1984-01-03
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1987-08-17
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1991-04-02
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1991-04-02
LABELING; LabelingSUPPL18AP1994-02-16
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1996-09-24
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1998-04-01
LABELING; LabelingSUPPL22AP2015-11-03

Submissions Property Types

SUPPL10Null0
SUPPL12Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0
SUPPL20Null0
SUPPL22Null7

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84710
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OGEN","activeIngredients":"ESTROPIPATE","strength":"1.5MG\/GM","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OGEN","submission":"ESTROPIPATE","actionType":"1.5MG\/GM","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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