Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 200MG;25MG;25MG | 0 | EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE | EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-09-27 | STANDARD |
Submissions Property Types
CDER Filings
CIPLA LIMITED
cder:Array
(
[0] => Array
(
[ApplNo] => 214058
[companyName] => CIPLA LIMITED
[docInserts] => ["",""]
[products] => [{"drugName":"EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE","activeIngredients":"EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE","strength":"200MG;25MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/27\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-09-27
)
)