ANDA 203470

PHARMACARE LTD

FDA Drug Application

Application #203470

Application Sponsors

ANDA 203470

PHARMACARE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET; ORAL

300MG

0

TENOFOVIR DISOPROXIL FUMARATE

TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-12-29

Submissions Property Types

ORIG

1

Null

19

CDER Filings

PHARMACARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203470
            [companyName] => PHARMACARE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"TENOFOVIR DISOPROXIL FUMARATE","strength":"300MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/29\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-29
        )

)