ANDA 065129

LUPIN PHARMS

FDA Drug Application

Application #065129

Application Sponsors

ANDA 065129

LUPIN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

FOR SUSPENSION;ORAL

100MG/5ML

0

SUPRAX

CEFIXIME

FDA Submissions

	ORIG	1	AP	2004-02-23
LABELING; Labeling	SUPPL	3	AP	2004-12-09
LABELING; Labeling	SUPPL	7	AP	2005-10-06
LABELING; Labeling	SUPPL	9	AP	2009-02-25
LABELING; Labeling	SUPPL	25	AP	2013-03-29	STANDARD
LABELING; Labeling	SUPPL	27	AP	2016-06-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2018-06-04

Submissions Property Types

SUPPL	25	Null	15
SUPPL	27	Null	7
SUPPL	32	Null	7

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65129
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUPRAX","activeIngredients":"CEFIXIME","strength":"100MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SUPRAX","submission":"CEFIXIME","actionType":"100MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)