ANDA 091475

HETERO LABS LTD III

FDA Drug Application

Application #091475

Documents

• Letter: 2012-05-31

Application Sponsors

ANDA 091475

HETERO LABS LTD III

Marketing Status

• None (Tentative Approval): 001

Application Products

001

SOLUTION; ORAL

10MG/ML

0

LAMIVUDINE

LAMIVUDINE

FDA Submissions

ORIG

1

TA

2012-05-29

Submissions Property Types

ORIG

1

Null

1

CDER Filings

HETERO LABS LTD III

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91475
            [companyName] => HETERO LABS LTD III
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"10MG\/ML","dosageForm":"SOLUTION; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LAMIVUDINE","submission":"LAMIVUDINE","actionType":"10MG\/ML","submissionClassification":"SOLUTION; ORAL","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)