NDA 010355

ROCHE

FDA Drug Application

Application #010355

Application Sponsors

NDA 010355

ROCHE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	2.5MG	0	QUARZAN	CLIDINIUM BROMIDE
002	CAPSULE;ORAL	5MG	0	QUARZAN	CLIDINIUM BROMIDE

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10355
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUARZAN","activeIngredients":"CLIDINIUM BROMIDE","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"QUARZAN","activeIngredients":"CLIDINIUM BROMIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"QUARZAN","submission":"CLIDINIUM BROMIDE","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"QUARZAN","submission":"CLIDINIUM BROMIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)