HETERO LABS LTD III FDA Approval ANDA 210692

ANDA 210692

HETERO LABS LTD III

FDA Drug Application

Application #210692

Application Sponsors

ANDA 210692HETERO LABS LTD III

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL750MG/5ML0ATOVAQUONEATOVAQUONE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-11STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

HETERO LABS LTD III
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210692
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATOVAQUONE","activeIngredients":"ATOVAQUONE","strength":"750MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-11
        )

)

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