APOTEX FDA Approval ANDA 204367

ANDA 204367

APOTEX

FDA Drug Application

Application #204367

Application Sponsors

ANDA 204367APOTEX

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUSEQ 5MG BASE/100ML0ZOLEDRONIC ACIDZOLEDRONIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2015-12-24
LABELING; LabelingSUPPL2AP2017-10-25STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAP

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204367
            [companyName] => APOTEX
            [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":"12\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/25\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/25\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-10-25
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.