Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-12-04 | |
Submissions Property Types
CDER Filings
MICRO LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 204396
[companyName] => MICRO LABS
[docInserts] => ["",""]
[products] => [{"drugName":"EMTRICITABINE","activeIngredients":"EMTRICITABINE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/04\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-12-04
)
)