ANDA 205302

STRIDES ARCOLAB LTD

FDA Drug Application

Application #205302

Documents

• Letter: 2015-09-30

Application Sponsors

ANDA 205302

STRIDES ARCOLAB LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

25MG

0

RILPIVIRINE

RILPIVIRINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-09-29

STANDARD

Submissions Property Types

ORIG

1

Null

19

CDER Filings

STRIDES ARCOLAB LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205302
            [companyName] => STRIDES ARCOLAB LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RILPIVIRINE","activeIngredients":"RILPIVIRINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205302Orig1s000TALtr_corrected.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-09-29
        )

)