ANDA 203259

HETERO LABS LTD V

FDA Drug Application

Application #203259

Application Sponsors

ANDA 203259

HETERO LABS LTD V

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG;300MG

0

LAMIVUDINE AND ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-02-03

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203259
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE AND ZIDOVUDINE","activeIngredients":"LAMIVUDINE; ZIDOVUDINE","strength":"150MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-02-03
        )

)