NDA 205389

MICRO LABS LTD INDIA

FDA Drug Application

Application #205389

Documents

• Letter: 2018-02-23

Application Sponsors

NDA 205389

MICRO LABS LTD INDIA

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

001	TABLET;ORAL	50MG	0	EFAVIRENZ	EFAVIRENZ
002	TABLET;ORAL	100MG	0	EFAVIRENZ	EFAVIRENZ
003	TABLET;ORAL	200MG	0	EFAVIRENZ	EFAVIRENZ

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2018-02-23

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MICRO LABS LTD INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205389
            [companyName] => MICRO LABS LTD INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205389Orig1s000TAltredt.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-02-23
        )

)