ANDA 200734

TARO

FDA Drug Application

Application #200734

Documents

• Letter: 2014-07-15

Application Sponsors

ANDA 200734

TARO

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

FLUOCINONIDE

FLUOCINONIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2014-07-14

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200734
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE","activeIngredients":"FLUOCINONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/14\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/200734Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-07-14
        )

)