ANDA 078475

CIPLA LTD

FDA Drug Application

Application #078475

Application Sponsors

ANDA 078475

CIPLA LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

4MG/5ML(0.8MG/ML)

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

ORIG

1

TA

2014-05-29

Submissions Property Types

ORIG

1

Null

29

CDER Filings

CIPLA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78475
            [companyName] => CIPLA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"4MG\/5ML(0.8MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"4MG\/5ML(0.8MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)