ANDA 085665

ROERIG

FDA Drug Application

Application #085665

Application Sponsors

ANDA 085665

ROERIG

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	SUSTAIRE	THEOPHYLLINE
002	TABLET, EXTENDED RELEASE;ORAL	300MG	0	SUSTAIRE	THEOPHYLLINE

CDER Filings

ROERIG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85665
            [companyName] => ROERIG
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUSTAIRE","activeIngredients":"THEOPHYLLINE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SUSTAIRE","activeIngredients":"THEOPHYLLINE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUSTAIRE","submission":"THEOPHYLLINE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SUSTAIRE","submission":"THEOPHYLLINE","actionType":"300MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)