NDA 008983

ROCHE

FDA Drug Application

Application #008983

Application Sponsors

NDA 008983

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

ARFONAD

TRIMETHAPHAN CAMSYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1954-04-26	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1976-05-06
LABELING; Labeling	SUPPL	10	AP	1978-06-26
LABELING; Labeling	SUPPL	11	AP	1988-04-21

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 8983
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARFONAD","activeIngredients":"TRIMETHAPHAN CAMSYLATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARFONAD","submission":"TRIMETHAPHAN CAMSYLATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)