ANDA 208213

HETERO LABS LTD III

FDA Drug Application

Application #208213

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 208213

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MCG

0

ROFLUMILAST

ROFLUMILAST

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208213
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROFLUMILAST","activeIngredients":"ROFLUMILAST","strength":"500MCG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208213Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-23
        )

)