ANDA 040591

HIKMA INTL PHARMS

FDA Drug Application

Application #040591

Application Sponsors

ANDA 040591

HIKMA INTL PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

30MG

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

ORIG

1

AP

2007-01-10

TE Codes

001

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40591
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)