ANDA 206422

LUPIN

FDA Drug Application

Application #206422

Documents

• Letter: 2015-09-04

Application Sponsors

ANDA 206422

LUPIN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-09-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

LUPIN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206422
            [companyName] => LUPIN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206422Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-02
        )

)