ANDA 040458

MIKART

FDA Drug Application

Application #040458

Documents

• Review: 2006-04-20

Application Sponsors

ANDA 040458

MIKART

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

4MG/5ML

0

CARBINOXAMINE MALEATE

CARBINOXAMINE MALEATE

FDA Submissions

	ORIG	1	AP	2003-04-25
LABELING; Labeling	SUPPL	2	AP	2004-04-15
LABELING; Labeling	SUPPL	5	AP	2006-06-07
LABELING; Labeling	SUPPL	6	AP	2007-08-09
LABELING; Labeling	SUPPL	7	AP	2010-08-25

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40458
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBINOXAMINE MALEATE","activeIngredients":"CARBINOXAMINE MALEATE","strength":"4MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBINOXAMINE MALEATE","submission":"CARBINOXAMINE MALEATE","actionType":"4MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)