NDA 006525

ROCHE

FDA Drug Application

Application #006525

Application Sponsors

NDA 006525

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

GANTRISIN

SULFISOXAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1948-07-29	UNKNOWN
LABELING; Labeling	SUPPL	15	AP	1978-01-27
LABELING; Labeling	SUPPL	16	AP	1978-07-12
LABELING; Labeling	SUPPL	17	AP	1982-05-25
LABELING; Labeling	SUPPL	18	AP	1997-01-09
LABELING; Labeling	SUPPL	20	AP	1993-08-04

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 6525
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANTRISIN","activeIngredients":"SULFISOXAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GANTRISIN","submission":"SULFISOXAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)