ANDA 078533

APOTEX INC

FDA Drug Application

Application #078533

Application Sponsors

ANDA 078533

APOTEX INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE; IV (INFUSION)

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

ORIG

1

TA

2009-04-15

Submissions Property Types

ORIG

1

Null

0

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78533
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"EQ 4MG BASE\/5ML","submissionClassification":"INJECTABLE; IV (INFUSION)","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)