ANDA 065175

XGEN PHARMS

FDA Drug Application

Application #065175

Application Sponsors

ANDA 065175

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	2004-12-17
LABELING; Labeling	SUPPL	4	AP	2007-07-23

TE Codes

001

Prescription

AT

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65175
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"POWDER;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/GM","submissionClassification":"POWDER;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)