ANDA 207895

PHARMACARE LTD

FDA Drug Application

Application #207895

Application Sponsors

ANDA 207895

PHARMACARE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

600MG

0

EFAVIRENZ

EFAVIRENZ

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

PHARMACARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207895
            [companyName] => PHARMACARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EFAVIRENZ","activeIngredients":"EFAVIRENZ","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-19
        )

)