ANDA 076332

SUN PHARM INDS LTD

FDA Drug Application

Application #076332

Documents

• Letter: 2004-07-30

Application Sponsors

ANDA 076332

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	FOR SUSPENSION;ORAL	50MG/5ML	0	FLUCONAZOLE	FLUCONAZOLE
002	FOR SUSPENSION;ORAL	200MG/5ML	0	FLUCONAZOLE	FLUCONAZOLE

FDA Submissions

	ORIG	1	AP	2004-07-29
LABELING; Labeling	SUPPL	5	AP	2008-10-03

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76332
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"50MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"200MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"50MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"200MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)