ANDA 065183

UPSHER SMITH LABS

FDA Drug Application

Application #065183

Application Sponsors

ANDA 065183

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

POWDER;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	2005-05-03
LABELING; Labeling	SUPPL	8	AP	2007-01-18

TE Codes

001

Prescription

AT

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65183
            [companyName] => UPSHER SMITH LABS
            [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
        )

)