ANDA 065355

LUPIN PHARMS

FDA Drug Application

Application #065355

Application Sponsors

ANDA 065355

LUPIN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

200MG/5ML

0

SUPRAX

CEFIXIME

FDA Submissions

	ORIG	1	AP	2007-04-10
LABELING; Labeling	SUPPL	18	AP	2013-03-29	STANDARD
LABELING; Labeling	SUPPL	20	AP	2016-07-11	STANDARD

Submissions Property Types

SUPPL	18	Null	15
SUPPL	20	Null	7

TE Codes

001

Prescription

AB

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65355
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUPRAX","activeIngredients":"CEFIXIME","strength":"200MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUPRAX","submission":"CEFIXIME","actionType":"200MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)