ROCHE FDA Approval NDA 008414

NDA 008414

ROCHE

FDA Drug Application

Application #008414

Application Sponsors

NDA 008414ROCHE

Marketing Status

Discontinued002

Application Products

002OINTMENT;OPHTHALMICEQ 4% BASE0GANTRISINSULFISOXAZOLE DIOLAMINE

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 8414
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GANTRISIN","activeIngredients":"SULFISOXAZOLE DIOLAMINE","strength":"EQ 4% BASE","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GANTRISIN","submission":"SULFISOXAZOLE DIOLAMINE","actionType":"EQ 4% BASE","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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