ANDA 062524

UPSHER SMITH LABS

FDA Drug Application

Application #062524

Application Sponsors

ANDA 062524

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500,000 UNITS

0

NYSTATIN

NYSTATIN

FDA Submissions

	ORIG	1	AP	1985-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-07-16
LABELING; Labeling	SUPPL	8	AP	1992-09-11

Submissions Property Types

SUPPL

7

Null

0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62524
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"500,000 UNITS","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"500,000 UNITS","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)