ANDA 202042

MICRO LABS LTD

FDA Drug Application

Application #202042

Documents

• Letter: 2012-01-23

Application Sponsors

ANDA 202042

MICRO LABS LTD

Marketing Status

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

Application Products

001	CAPSULE; ORAL	50MG	0	EFAVIRENZ	EFAVIRENZ
002	CAPSULE; ORAL	200MG	0	EFAVIRENZ	EFAVIRENZ

FDA Submissions

N/A; Not Applicable

ORIG

1

TA

2012-01-19

Submissions Property Types

ORIG

1

Null

42

CDER Filings

MICRO LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202042
            [companyName] => MICRO LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"50MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"200MG","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2012","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202042s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-01-19
        )

)