ANDA 204051

SUN PHARMA GLOBAL

FDA Drug Application

Application #204051

Documents

• Letter: 2016-10-06

Application Sponsors

ANDA 204051

SUN PHARMA GLOBAL

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

4MG/100ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

ORIG

1

TA

2014-07-03

Submissions Property Types

ORIG

1

Null

0

CDER Filings

SUN PHARMA GLOBAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204051
            [companyName] => SUN PHARMA GLOBAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"4MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/03\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204051Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-07-03
        )

)