Application Sponsors
ANDA 208355 | AUROBINDO PHARMA LTD | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 50MG | 0 | DOLUTEGRAVIR SODIUM | DOLUTEGRAVIR SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2016-09-19 | STANDARD |
Submissions Property Types
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 208355
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DOLUTEGRAVIR SODIUM","activeIngredients":"DOLUTEGRAVIR SODIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/19\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-09-19
)
)