Application Sponsors
ANDA 204138 | SUN PHARMA GLOBAL | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | INJECTABLE;INJECTION | 5MG/100ML | 0 | ZOLEDRONIC ACID | ZOLEDRONIC ACID |
FDA Submissions
Submissions Property Types
CDER Filings
SUN PHARMA GLOBAL
cder:Array
(
[0] => Array
(
[ApplNo] => 204138
[companyName] => SUN PHARMA GLOBAL
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"5MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/22\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-07-22
)
)