MEDLEY PHARMS FDA Approval ANDA 214346

ANDA 214346

MEDLEY PHARMS

FDA Drug Application

Application #214346

Application Sponsors

ANDA 214346MEDLEY PHARMS

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL100,000 UNITS/ML0NYSTATINNYSTATIN

FDA Submissions

UNKNOWN; ORIG1AP2022-03-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

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
        )

)

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