3M FDA Approval ANDA 086107

ANDA 086107

3M

FDA Drug Application

Application #086107

Application Sponsors

ANDA 0861073M

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORAL80MG/15ML0THEOLAIRTHEOPHYLLINE

FDA Submissions

ORIG1AP1979-03-26
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1985-06-18
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1985-06-18
LABELING; LabelingSUPPL6AP1991-06-12
LABELING; LabelingSUPPL8AP1996-09-20

Submissions Property Types

ORIG1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0

CDER Filings

3M
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86107
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOLAIR","activeIngredients":"THEOPHYLLINE","strength":"80MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOLAIR","submission":"THEOPHYLLINE","actionType":"80MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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