INVAGEN PHARMS FDA Approval ANDA 090435

ANDA 090435

INVAGEN PHARMS

FDA Drug Application

Application #090435

Application Sponsors

ANDA 090435INVAGEN PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL4MG0CARBINOXAMINE MALEATECARBINOXAMINE MALEATE

FDA Submissions

ORIG1AP2010-04-15

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90435
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBINOXAMINE MALEATE","activeIngredients":"CARBINOXAMINE MALEATE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBINOXAMINE MALEATE","submission":"CARBINOXAMINE MALEATE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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