MACLEODS PHARMS LTD FDA Approval ANDA 214181

ANDA 214181

MACLEODS PHARMS LTD

FDA Drug Application

Application #214181

Application Sponsors

ANDA 214181MACLEODS PHARMS LTD

Marketing Status

Prescription001

Application Products

001CREAM;TOPICAL100,000 UNITS/GM;0.1%0NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAT

CDER Filings

MACLEODS PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214181
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN AND TRIAMCINOLONE ACETONIDE","activeIngredients":"NYSTATIN; TRIAMCINOLONE ACETONIDE","strength":"100,000 UNITS\/GM;0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-13
        )

)

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