ANDA 202161

TARO

FDA Drug Application

Application #202161

Documents

• Letter: 2014-11-05

Application Sponsors

ANDA 202161

TARO

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

DESONIDE

DESONIDE

FDA Submissions

ORIG

1

AP

2014-10-31

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202161
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DESONIDE","activeIngredients":"DESONIDE","strength":"0.05%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202161Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-31
        )

)