ANDA 075314

SUN PHARM INDUSTRIES

FDA Drug Application

Application #075314

Documents

• Letter: 1999-06-15

Application Sponsors

ANDA 075314

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

	ORIG	1	AP	1999-06-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-16
LABELING; Labeling	SUPPL	12	AP	2017-10-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	12	Null	7

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75314
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOCONAZOLE","submission":"KETOCONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)