ANDA 210692

HETERO LABS LTD III

FDA Drug Application

Application #210692

Application Sponsors

ANDA 210692

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

750MG/5ML

0

ATOVAQUONE

ATOVAQUONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-10-11

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

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
        )

)