NOVO NORDISK INC FDA Approval ANDA 040312

ANDA 040312

NOVO NORDISK INC

FDA Drug Application

Application #040312

Documents

Letter1999-11-19
Review1999-11-19

Application Sponsors

ANDA 040312NOVO NORDISK INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL0.5MG0INNOFEMESTRADIOL
002TABLET;ORAL1MG0INNOFEMESTRADIOL
003TABLET;ORAL2MG0INNOFEMESTRADIOL

FDA Submissions

ORIG1AP1999-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-07-15

Submissions Property Types

SUPPL1Null0
SUPPL2Null0

CDER Filings

NOVO NORDISK INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40312
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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