ABBVIE FDA Approval NDA 006905

NDA 006905

ABBVIE

FDA Drug Application

Application #006905

Application Sponsors

NDA 006905ABBVIE

Marketing Status

Discontinued002
Discontinued003

Application Products

002POWDER;INHALATION25%0NORISODRINEISOPROTERENOL SULFATE
003POWDER;INHALATION10%0NORISODRINEISOPROTERENOL SULFATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL2AP1975-06-25STANDARD
LABELING; LabelingSUPPL5AP1976-02-03
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1981-01-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1982-01-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1983-10-29STANDARD
LABELING; LabelingSUPPL11AP1983-10-29

Submissions Property Types

SUPPL2Null0
SUPPL6Null0
SUPPL7Null0
SUPPL10Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6905
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORISODRINE","activeIngredients":"ISOPROTERENOL SULFATE","strength":"25%","dosageForm":"POWDER;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NORISODRINE","activeIngredients":"ISOPROTERENOL SULFATE","strength":"10%","dosageForm":"POWDER;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NORISODRINE","submission":"ISOPROTERENOL SULFATE","actionType":"25%","submissionClassification":"POWDER;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NORISODRINE","submission":"ISOPROTERENOL SULFATE","actionType":"10%","submissionClassification":"POWDER;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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