ANDA 065130

LUPIN PHARMS

FDA Drug Application

Application #065130

Application Sponsors

ANDA 065130

LUPIN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG

0

SUPRAX

CEFIXIME

FDA Submissions

	ORIG	1	AP	2004-02-12
LABELING; Labeling	SUPPL	4	AP	2012-01-17
LABELING; Labeling	SUPPL	16	AP	2013-03-29	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-02-16	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	16	Null	15
SUPPL	18	Null	15

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65130
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUPRAX","activeIngredients":"CEFIXIME","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUPRAX","submission":"CEFIXIME","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)