ANDA 205895

ALKEM LABS LTD

FDA Drug Application

Application #205895

Documents

• Letter: 2016-01-06

Application Sponsors

ANDA 205895

ALKEM LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

400MG

0

DRONEDARONE HYDROCHLORIDE

DRONEDARONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-12-31

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205895
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONEDARONE HYDROCHLORIDE","activeIngredients":"DRONEDARONE HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/31\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205895Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-31
        )

)