ANDA 040442

MIKART

FDA Drug Application

Application #040442

Application Sponsors

ANDA 040442

MIKART

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

4MG

0

CARBINOXAMINE MALEATE

CARBINOXAMINE MALEATE

FDA Submissions

	ORIG	1	AP	2003-03-19
LABELING; Labeling	SUPPL	3	AP	2006-06-07
LABELING; Labeling	SUPPL	4	AP	2007-04-12
LABELING; Labeling	SUPPL	6	AP	2010-08-25

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40442
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBINOXAMINE MALEATE","activeIngredients":"CARBINOXAMINE MALEATE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBINOXAMINE MALEATE","submission":"CARBINOXAMINE MALEATE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)