ANDA 086168

SUN PHARM INDUSTRIES

FDA Drug Application

Application #086168

Application Sponsors

ANDA 086168

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

5MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)

SUPPL

44

AP

1998-12-01

Submissions Property Types

SUPPL

44

Null

0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86168
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)