ANDA 208124

LUPIN ATLANTIS

FDA Drug Application

Application #208124

Documents

• Letter: 2018-04-05

Application Sponsors

ANDA 208124

LUPIN ATLANTIS

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;TOPICAL

0.25%

0

DESOXIMETASONE

DESOXIMETASONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

LUPIN ATLANTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208124
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESOXIMETASONE","activeIngredients":"DESOXIMETASONE","strength":"0.25%","dosageForm":"SPRAY;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208124Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-16
        )

)