ANDA 209596

GLASSHOUSE PHARMS

FDA Drug Application

Application #209596

Application Sponsors

ANDA 209596

GLASSHOUSE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

GLASSHOUSE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209596
            [companyName] => GLASSHOUSE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-26
        )

)