ANDA 040506

MIKART

FDA Drug Application

Application #040506

Application Sponsors

ANDA 040506

MIKART

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

ETHOSUXIMIDE

ETHOSUXIMIDE

FDA Submissions

	ORIG	1	AP	2003-12-22
LABELING; Labeling	SUPPL	2	AP	2008-08-15
LABELING; Labeling	SUPPL	3	AP	2009-12-10
LABELING; Labeling	SUPPL	4	AP	2014-01-10	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40506
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHOSUXIMIDE","activeIngredients":"ETHOSUXIMIDE","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ETHOSUXIMIDE","submission":"ETHOSUXIMIDE","actionType":"250MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)