ANDA 207484

MIKART

FDA Drug Application

Application #207484

Application Sponsors

ANDA 207484

MIKART

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

6MG

0

CARBINOXAMINE MALEATE

CARBINOXAMINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-05-31

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207484
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBINOXAMINE MALEATE","activeIngredients":"CARBINOXAMINE MALEATE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-31
        )

)