ANDA 213566

MACLEODS PHARMS LTD

FDA Drug Application

Application #213566

Application Sponsors

ANDA 213566

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

100,000 UNITS/GM

0

NYSTATIN

NYSTATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-10

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213566
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/GM","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-10
        )

)