ANDA 205082

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #205082

Documents

• Letter: 2015-09-09

Application Sponsors

ANDA 205082

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.25%

0

DESOXIMETASONE

DESOXIMETASONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-09-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205082
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOXIMETASONE","activeIngredients":"DESOXIMETASONE","strength":"0.25%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205082Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-04
        )

)