ANDA 207133

PERRIGO UK FINCO

FDA Drug Application

Application #207133

Documents

• Letter: 2016-08-30

Application Sponsors

ANDA 207133

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

FLURANDRENOLIDE

FLURANDRENOLIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-30

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207133
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURANDRENOLIDE","activeIngredients":"FLURANDRENOLIDE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207133Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-30
        )

)