NDA 016191

ASTRAZENECA

FDA Drug Application

Application #016191

Application Sponsors

NDA 016191

ASTRAZENECA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;SUBLINGUAL	5MG	0	SORBITRATE	ISOSORBIDE DINITRATE
002	TABLET;SUBLINGUAL	2.5MG	0	SORBITRATE	ISOSORBIDE DINITRATE

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16191
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"2.5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"2.5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)