ANDA 200406

MICRO LABS LTD

FDA Drug Application

Application #200406

Application Sponsors

ANDA 200406

MICRO LABS LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET; ORAL	150MG	0	LAMIVUDINE	LAMIVUDINE
002	TABLET; ORAL	300MG	0	LAMIVUDINE	LAMIVUDINE

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2012-05-30

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MICRO LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200406
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/30\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-05-30
        )

)