NDA 013664

ROCHE

FDA Drug Application

Application #013664

Application Sponsors

NDA 013664

ROCHE

Marketing Status

• Discontinued: 002

Application Products

002

SUSPENSION;ORAL

500MG/5ML

0

GANTANOL

SULFAMETHOXAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1965-07-01	STANDARD
LABELING; Labeling	SUPPL	18	AP	1978-01-05
LABELING; Labeling	SUPPL	19	AP	1997-01-09
LABELING; Labeling	SUPPL	20	AP	1997-01-09

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13664
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANTANOL","activeIngredients":"SULFAMETHOXAZOLE","strength":"500MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GANTANOL","submission":"SULFAMETHOXAZOLE","actionType":"500MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)