ROCHE FDA Approval NDA 016149

NDA 016149

ROCHE

FDA Drug Application

Application #016149

Application Sponsors

NDA 016149ROCHE

Marketing Status

Discontinued002

Application Products

002CONCENTRATE;ORAL100MG/5ML0TARACTANCHLORPROTHIXENE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1967-06-19STANDARD
LABELING; LabelingSUPPL13AP1974-06-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1976-09-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1979-05-04STANDARD
LABELING; LabelingSUPPL21AP1979-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1979-01-10STANDARD
LABELING; LabelingSUPPL24AP1981-01-29STANDARD

Submissions Property Types

ORIG1Null0
SUPPL13Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL24Null0

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16149
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"100MG\/5ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"100MG\/5ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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