NDA 013294

ROCHE

FDA Drug Application

Application #013294

Application Sponsors

NDA 013294

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

AZO GANTANOL

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13294
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZO GANTANOL","activeIngredients":"PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE","strength":"100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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 GANTANOL","submission":"PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE","actionType":"100MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":"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
        )

)