NDA 019358

ROCHE

FDA Drug Application

Application #019358

Application Sponsors

NDA 019358

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

AZO GANTRISIN

PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

1990-08-31

STANDARD

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19358
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZO GANTRISIN","activeIngredients":"PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE","strength":"50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZO GANTRISIN","submission":"PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE","actionType":"50MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)