Application Sponsors
ANDA 209125 | AUROBINDO PHARMA LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 5MG BASE/100ML | 0 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-12-08 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209125
[companyName] => AUROBINDO PHARMA LTD
[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\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-12-08
)
)