Application Sponsors
ANDA 091364 | DR REDDYS LABS LTD | |
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
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 91364
[companyName] => DR REDDYS LABS LTD
[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":"ZOLEDRONIC ACID","submission":"ZOLEDRONIC ACID","actionType":"5MG\/100ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"None (Tentative Approval)","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)