ANDA 200174

PERRIGO UK FINCO

FDA Drug Application

Application #200174

Documents

• Letter: 2014-12-17

Application Sponsors

ANDA 200174

PERRIGO UK FINCO

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.064%;0.005%

0

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2014-12-12

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO UK FINCO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200174
            [companyName] => PERRIGO UK FINCO
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200174Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-12-12
        )

)