ANDA 208167

ZYDUS PHARMS USA INC

FDA Drug Application

Application #208167

Application Sponsors

ANDA 208167

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

20MG/20ML

0

CLOFARABINE

CLOFARABINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-03-04

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208167
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOFARABINE","activeIngredients":"CLOFARABINE","strength":"20MG\/20ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-04
        )

)