Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | 0 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-12-24 | |
LABELING; Labeling | SUPPL | 2 | AP | 2017-10-25 | STANDARD |
Submissions Property Types
TE Codes
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
)
)