ANDA 079124

HETERO LABS LTD III

FDA Drug Application

Application #079124

Documents

• Letter: 2008-04-28

Application Sponsors

ANDA 079124

HETERO LABS LTD III

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

150MG;300MG

0

LAMIVUDINE AND ZIDOVUDINE

LAMIVUDINE; ZIDOVUDINE

FDA Submissions

ORIG

1

AP

2015-09-17

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79124
            [companyName] => HETERO LABS LTD III
            [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":"LAMIVUDINE AND ZIDOVUDINE","submission":"LAMIVUDINE; ZIDOVUDINE","actionType":"150MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)