3M FDA Approval ANDA 088364

ANDA 088364

3M

FDA Drug Application

Application #088364

Application Sponsors

ANDA 0883643M

Marketing Status

Discontinued001

Application Products

001TABLET, EXTENDED RELEASE;ORAL300MG0THEOLAIR-SRTHEOPHYLLINE

FDA Submissions

ORIG1AP1987-07-16
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1989-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-01-15
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-01-15
LABELING; LabelingSUPPL6AP1991-02-15
LABELING; LabelingSUPPL8AP1998-05-29
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-10-08
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-07-06
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-12-03

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0

CDER Filings

3M
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88364
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"THEOLAIR-SR","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THEOLAIR-SR","submission":"THEOPHYLLINE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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