ANDA 200918

AKORN

FDA Drug Application

Application #200918

Application Sponsors

ANDA 200918

AKORN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 5MG BASE/100ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2014-08-21

Submissions Property Types

ORIG

1

Null

19

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200918
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 5MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/14\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-12-14
        )

)