ANDA 210539

GLENMARK PHARMS LTD

FDA Drug Application

Application #210539

Application Sponsors

ANDA 210539

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

OIL;TOPICAL

0.01%

0

FLUOCINONIDE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210539
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"OIL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-26
        )

)