ALKEM LABS LTD FDA Approval ANDA 205895

ANDA 205895

ALKEM LABS LTD

FDA Drug Application

Application #205895

Documents

Letter2016-01-06

Application Sponsors

ANDA 205895ALKEM LABS LTD

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL400MG0DRONEDARONE HYDROCHLORIDEDRONEDARONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2015-12-31STANDARD

Submissions Property Types

ORIG1Null1

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
        )

)

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