ABBVIE FDA Approval NDA 019204

NDA 019204

ABBVIE

FDA Drug Application

Application #019204

Application Sponsors

NDA 019204ABBVIE

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL2.5MG0CARTROLCARTEOLOL HYDROCHLORIDE
002TABLET;ORAL5MG0CARTROLCARTEOLOL HYDROCHLORIDE
003TABLET;ORAL10MG0CARTROLCARTEOLOL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1988-12-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-04-16STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19204
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARTROL","activeIngredients":"CARTEOLOL HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARTROL","activeIngredients":"CARTEOLOL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARTROL","activeIngredients":"CARTEOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARTROL","submission":"CARTEOLOL HYDROCHLORIDE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARTROL","submission":"CARTEOLOL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARTROL","submission":"CARTEOLOL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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