3M FDA Approval NDA 012102

NDA 012102

3M

FDA Drug Application

Application #012102

Application Sponsors

NDA 0121023M

Marketing Status

Discontinued001

Application Products

001AEROSOL, METERED;INHALATION0.36MG/INH0MEDIHALER ERGOTAMINEERGOTAMINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1960-01-13STANDARD
LABELING; LabelingSUPPL5AP1979-06-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1982-03-10STANDARD

Submissions Property Types

ORIG1Null0
SUPPL5Null0
SUPPL6Null0

CDER Filings

3M
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12102
            [companyName] => 3M
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEDIHALER ERGOTAMINE","activeIngredients":"ERGOTAMINE TARTRATE","strength":"0.36MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEDIHALER ERGOTAMINE","submission":"ERGOTAMINE TARTRATE","actionType":"0.36MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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