ANDA 203344

PFIZER INC

FDA Drug Application

Application #203344

Application Sponsors

ANDA 203344

PFIZER INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

4MG/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-02-09

Submissions Property Types

ORIG

1

Null

42

CDER Filings

PFIZER INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203344
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"4MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-02-09
        )

)