ROCHE FDA Approval NDA 012487

NDA 012487

ROCHE

FDA Drug Application

Application #012487

Application Sponsors

NDA 012487ROCHE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION12.5MG/ML0TARACTANCHLORPROTHIXENE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1962-03-23STANDARD
LABELING; LabelingSUPPL12AP1974-06-16
LABELING; LabelingSUPPL14AP1997-06-25
LABELING; LabelingSUPPL17AP1979-01-08
LABELING; LabelingSUPPL18AP1997-06-25
LABELING; LabelingSUPPL19AP1981-01-29
LABELING; LabelingSUPPL20AP1997-06-25
LABELING; LabelingSUPPL21AP1984-09-27
LABELING; LabelingSUPPL23AP1997-06-25
LABELING; LabelingSUPPL24AP1997-06-25
LABELING; LabelingSUPPL25AP1997-06-25

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12487
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TARACTAN","activeIngredients":"CHLORPROTHIXENE","strength":"12.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TARACTAN","submission":"CHLORPROTHIXENE","actionType":"12.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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