ANDA 065323

SUN PHARM INDS LTD

FDA Drug Application

Application #065323

Application Sponsors

ANDA 065323

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML	0	CEFUROXIME AXETIL	CEFUROXIME AXETIL
002	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML	0	CEFUROXIME AXETIL	CEFUROXIME AXETIL

FDA Submissions

ORIG

1

AP

2008-02-05

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65323
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFUROXIME AXETIL","activeIngredients":"CEFUROXIME AXETIL","strength":"EQ 125MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFUROXIME AXETIL","activeIngredients":"CEFUROXIME AXETIL","strength":"EQ 250MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFUROXIME AXETIL","submission":"CEFUROXIME AXETIL","actionType":"EQ 125MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME AXETIL","submission":"CEFUROXIME AXETIL","actionType":"EQ 250MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)