NDA 012715

ROCHE

FDA Drug Application

Application #012715

Application Sponsors

NDA 012715

ROCHE

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET;ORAL	500MG	0	GANTANOL	SULFAMETHOXAZOLE
003	TABLET;ORAL	1GM	0	GANTANOL-DS	SULFAMETHOXAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1965-08-25	STANDARD
LABELING; Labeling	SUPPL	19	AP	1977-05-04
LABELING; Labeling	SUPPL	20	AP	1978-01-05
LABELING; Labeling	SUPPL	24	AP	1978-05-04
LABELING; Labeling	SUPPL	25	AP	2001-09-17
LABELING; Labeling	SUPPL	27	AP	2001-09-17
LABELING; Labeling	SUPPL	29	AP	2001-09-17

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12715
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANTANOL","activeIngredients":"SULFAMETHOXAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GANTANOL-DS","activeIngredients":"SULFAMETHOXAZOLE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GANTANOL","submission":"SULFAMETHOXAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GANTANOL-DS","submission":"SULFAMETHOXAZOLE","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)