ANDA 214346

MEDLEY PHARMS

FDA Drug Application

Application #214346

Application Sponsors

ANDA 214346

MEDLEY PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100,000 UNITS/ML

0

NYSTATIN

NYSTATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-10

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

MEDLEY PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214346
            [companyName] => MEDLEY PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-10
        )

)