ZYDUS PHARMS USA INC FDA Approval ANDA 208167

ANDA 208167

ZYDUS PHARMS USA INC

FDA Drug Application

Application #208167

Application Sponsors

ANDA 208167ZYDUS PHARMS USA INC

Marketing Status

None (Tentative Approval)001

Application Products

001INJECTABLE;INJECTION20MG/20ML0CLOFARABINECLOFARABINE

FDA Submissions

UNKNOWN; ORIG1TA2016-03-04STANDARD

Submissions Property Types

ORIG1Null31

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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.